Trial Outcomes & Findings for A Trial to Determine the Efficacy and Safety of Presendin in IIH (NCT NCT05347147)
NCT ID: NCT05347147
Last Updated: 2024-04-24
Results Overview
ICP was measured by LP (opening pressure) using an LP manometer; Baseline and Week 24 ICP values (measured in cm CSF) are presented for each subject. A standard operating procedure was followed by all study sites for all study-related ICP measurements by LP.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
Presendin
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Presendin
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Sponsor request
|
3
|
3
|
|
Overall Study
Study termination
|
2
|
1
|
Baseline Characteristics
A Trial to Determine the Efficacy and Safety of Presendin in IIH
Baseline characteristics by cohort
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.0 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
28.5 Years
STANDARD_DEVIATION 5.32 • n=7 Participants
|
28.2 Years
STANDARD_DEVIATION 7.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than 1 Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
ICP was measured by LP (opening pressure) using an LP manometer; Baseline and Week 24 ICP values (measured in cm CSF) are presented for each subject. A standard operating procedure was followed by all study sites for all study-related ICP measurements by LP.
Outcome measures
| Measure |
Presendin
n=2 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=1 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 1 Baseline ICP
|
25 cm CSF
|
—
|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 1 Week 24 ICP
|
28 cm CSF
|
—
|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 2 Baseline ICP
|
28 cm CSF
|
—
|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 2 Week 24 ICP
|
29 cm CSF
|
—
|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 3 Baseline ICP
|
—
|
40 cm CSF
|
|
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Subject 3 Week 24 ICP
|
—
|
30 cm CSF
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represent collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a "study eye". For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
Outcome measures
| Measure |
Presendin
n=4 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=5 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 1: right eye, Baseline PMD
|
-5.89 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 1: right eye, Week 24 PMD
|
0.74 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 2: right eye, Baseline PMD
|
-3.60 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 2: right eye, Week 24 PMD
|
-1.09 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 3: right eye, Baseline PMD
|
—
|
-2.79 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 3: right eye, Week 24 PMD
|
—
|
-1.50 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 3: left eye, Baseline PMD
|
—
|
-4.78 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 3: left eye, Week 24 PMD
|
—
|
-2.33 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 4: right eye, Baseline PMD
|
—
|
-3.16 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 4: right eye, Week 24 PMD
|
—
|
-2.20 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 4: left eye, Baseline PMD
|
—
|
-2.36 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 4: left eye, Week 24 PMD
|
—
|
-1.60 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 5: right eye, Baseline PMD
|
—
|
-2.24 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 5: right eye, Week 24 PMD
|
—
|
-2.69 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 5: left eye, Baseline PMD
|
—
|
-3.66 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 5: left eye, Week 24 PMD
|
—
|
-2.98 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 6: right eye, Baseline PMD
|
-3.64 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 6: right eye, Week 24 PMD
|
-0.88 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 6: left eye, Baseline PMD
|
-2.55 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 6: left eye, Week 24 PMD
|
0.15 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 7: right eye, Baseline PMD
|
—
|
-2.54 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 7: right eye, Week 24 PMD
|
—
|
-0.49 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 7: left eye, Baseline PMD
|
—
|
-3.15 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 7: left eye, Week 24 PMD
|
—
|
-0.26 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 8: left eye, Baseline PMD
|
—
|
-2.6 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 8: left eye, Week 24 PMD
|
—
|
-1.5 dB
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 9: right eye, Baseline PMD
|
-2.37 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 9: right eye, Week 24 PMD
|
-2.59 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 9: left eye, Baseline PMD
|
-3.81 dB
|
—
|
|
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Subject 9: left eye, Week 24 PMD
|
-2.04 dB
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a "study eye". For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. Cirrus was the imaging platform used for all subjects except Subjects 6 and 7, where Zeiss was used.
Outcome measures
| Measure |
Presendin
n=4 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=4 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 1: right eye, Baseline RNFL
|
115 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 1: right eye, Week 24 RNFL
|
105 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 2: right eye, Baseline RNFL
|
199 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 2: right eye, Week 24 RNFL
|
173 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 3: right eye, Baseline RNFL
|
—
|
140 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 3: right eye, Week 24 RNFL
|
—
|
155 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 3: left eye, Baseline RNFL
|
—
|
114 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 3: left eye, Week 24 RNFL
|
—
|
122 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 4: right eye, Baseline RNFL
|
—
|
432 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 4: right eye, Week 24 RNFL
|
—
|
372 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 4: left eye, Baseline RNFL
|
—
|
358 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 4: left eye, Week 24 RNFL
|
—
|
317 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 5: right eye, Baseline RNFL
|
—
|
127 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 5: right eye, Week 24 RNFL
|
—
|
119 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 5: left eye, Baseline RNFL
|
—
|
121 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 5: left eye, Week 24 RNFL
|
—
|
126 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 6: right eye, Baseline RNFL
|
111 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 6: right eye, Week 24 RNFL
|
101 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 6: left eye, Baseline RNFL
|
111 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 6: left eye, Week 24 RNFL
|
105 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 7: right eye, Baseline RNFL
|
—
|
114 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 7: right eye, Week 24 RNFL
|
—
|
107 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 7: left eye, Baseline RNFL
|
—
|
119 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 7: left eye, Week 24 RNFL
|
—
|
111 µm
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 8: right eye, Baseline RNFL
|
81 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 8: right eye, Week 24 RNFL
|
74 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 8: left eye, Baseline RNFL
|
132 µm
|
—
|
|
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Subject 8: left eye, Week 24 RNFL
|
92 µm
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a "study eye". For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
Outcome measures
| Measure |
Presendin
n=3 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=4 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 6, right eye
|
-11.87 percentage change
|
—
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 6, left eye
|
-8.10 percentage change
|
—
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 1, right eye
|
-6.67 percentage change
|
—
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 2, right eye
|
18.64 percentage change
|
—
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 3, right eye
|
—
|
8.61 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 3, left eye
|
—
|
2.61 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 4, right eye
|
—
|
0.77 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 4, left eye
|
—
|
2.35 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 5, right eye
|
—
|
-1.53 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 5, left eye
|
—
|
11.41 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 7, right eye
|
—
|
-2.82 percentage change
|
|
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Subject 7, left eye
|
—
|
-6.46 percentage change
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. The number of days on which data were collected for each subject during the 7-day baseline period and the last 28-day period are provided in parentheses in the row titles. No data were collected for Subject 7 during the 7-day baseline period.
Monthly headache days (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on \>7 days and where ≥1 headache on a day met the following criteria: * Onset, continuation, or recurrence of headache * Any severity or phenotype of headache * Lasts at least 30 minutes Baseline headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the MHD during the baseline period (linearly scaled to a maximum of 28 days) and the last 28-day period during which data were collected on \>7 days for each subject prior to study completion or discontinuation. Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
The Number of Monthly Headache Days (MHD)
Subject 1 Baseline (5 days)
|
28 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 1 28-day period 6 (14 days)
|
28 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 2 Baseline (7 days)
|
20 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 2 28-day period 6 (24 days)
|
3.5 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 3 Baseline (7 days)
|
—
|
28 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 3 28-day period 6 (9 days)
|
—
|
28 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 4 Baseline (5 days)
|
28 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 4 28-day period 4 (11 days)
|
28 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 5 Baseline (2 days)
|
NA Monthly headache days
Data were collected on 2 days, therefore the baseline value was not valid
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 5 28-day period 4 (10 days)
|
5.6 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 6 Baseline (4 days)
|
—
|
NA Monthly headache days
Data were collected on 4 days, therefore the baseline value was not valid
|
|
The Number of Monthly Headache Days (MHD)
Subject 6 28-day period 2 (10 days)
|
—
|
11.2 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 7 28-day period 4 (7 days)
|
—
|
16 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 8 Baseline (6 days)
|
—
|
23.33 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 8 28-day period 2 (8 days)
|
—
|
28 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 9 Baseline (6 days)
|
14 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 9 28-day period 6 (18 days)
|
9.33 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 10 Baseline (7 days)
|
20 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 10 28-day period 4 (12 days)
|
18.67 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 11 Baseline (7 days)
|
—
|
20 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 11 28-day period 4 (15 days)
|
—
|
5.6 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 12 Baseline (4 days)
|
NA Monthly headache days
Data were collected on 4 days, therefore the baseline value was not valid
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 12 28-day period 1(27 days)
|
23.85 Monthly headache days
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 13 Baseline (7 days)
|
—
|
20 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 13 28-day period 4 (21 days)
|
—
|
1.3 Monthly headache days
|
|
The Number of Monthly Headache Days (MHD)
Subject 14 Baseline (3 days)
|
NA Monthly headache days
Data were collected on 3 days, therefore the baseline value was not valid
|
—
|
|
The Number of Monthly Headache Days (MHD)
Subject 14 28-day period 3 (10 days)
|
0 Monthly headache days
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. The number of days on which data were collected for each subject during the 7-day baseline period and the last 28-day period are provided in parentheses in the row titles. No data were collected for Subject 7 during the 7-day baseline period.
Moderate to severe (m-s) MHD (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on \>7 days and where ≥1 headache on a day met the following criteria: * Severity was of moderate or severe pain and lasted at least 4 hours or, * Required acute headache analgesics Baseline m-s headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of m-s headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the m-s MHD during the baseline period (linearly scaled to a max 28 days) and the last 28-day period during which data were collected on \>7 days for each subject prior to study completion or discontinuation. Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Number of Moderate to Severe MHD
Subject 1 Baseline (5 days)
|
5.6 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 1 28-day period 6 (14 days)
|
10 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 2 Baseline (7 days)
|
12 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 2 28-day period 6 (24 days)
|
1.167 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 3 Baseline (7 days)
|
—
|
8 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 3 28-day period 6 (9 days)
|
—
|
24.889 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 4 Baseline (5 days)
|
16.8 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 4 28-day period 4 (11 days)
|
28 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 5 Baseline (2 days)
|
NA Monthly headache days
Data were collected on 2 days, therefore the baseline value was not valid
|
—
|
|
Number of Moderate to Severe MHD
Subject 5 28-day period 4 (10 days)
|
0 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 6 Baseline (4 days)
|
—
|
NA Monthly headache days
Data were collected on 4 days, therefore the baseline value was not valid
|
|
Number of Moderate to Severe MHD
Subject 6 28-day period 2 (10 days)
|
—
|
5.6 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 7 28-day period 4 (7 days)
|
—
|
0 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 8 Baseline (6 days)
|
—
|
9.333 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 8 28-day period 2 (8 days)
|
—
|
28 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 9 Baseline (6 days)
|
14 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 9 28-day period 6 (18 days)
|
0 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 10 Baseline (7 days)
|
20 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 10 28-day period 4 (12 days)
|
14 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 11 Baseline (7 days)
|
—
|
4 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 11 28-day period 4 (15 days)
|
—
|
0 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 12 Baseline (4 days)
|
NA Monthly headache days
Data were collected on 4 days, therefore the baseline value was not valid
|
—
|
|
Number of Moderate to Severe MHD
Subject 12 28-day period 1 (27 days)
|
18.667 Monthly headache days
|
—
|
|
Number of Moderate to Severe MHD
Subject 13 Baseline (7 days)
|
—
|
8 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 13 28-day period 4 (21 days)
|
—
|
1.333 Monthly headache days
|
|
Number of Moderate to Severe MHD
Subject 14 Baseline (3 days)
|
NA Monthly headache days
Data were collected on 3 days, therefore the baseline value was not valid
|
—
|
|
Number of Moderate to Severe MHD
Subject 14 28-day period 3 (10 days)
|
0 Monthly headache days
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The number of responders is provided for all subjects (including those who were considered non-responders because they dropped out of the study prior to Week 24) and for subjects who completed the study.
A subject was considered a responder if they had at least a 50% reduction in MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders.
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
Number of responders (subjects who completed the study)
|
1 Participants
|
0 Participants
|
|
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
Number of responders (all subjects)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The number of responders is provided for all subjects (including those who were considered non-responders because they dropped out of the study prior to Week 24) and for subjects who completed the study.
A subject was considered a responder if they had at least a 50% reduction in moderate to severe MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders.
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)
Number of responders (subjects who completed the study)
|
2 Participants
|
0 Participants
|
|
Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)
Number of responders (all subjects)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects. For anonymity, study-assigned subject IDs are not included and subject numbers used throughout ClinicalTrials.gov results do not consistently relate to the same subjects. Number of days on which severity data were collected for each subject during the 7-day baseline and the last 28-day periods are provided in row titles.
Headache severity was assessed by a 10-point Numeric Rating Scale (NRS), 0-10 where 0 = no pain and 10 = most severe pain. Severity of headaches was assessed on days where a headache occurred. Headache free days were not counted. Baseline headache severity was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days of headache severity data had to be recorded by the subject to obtain a valid baseline value. * 28-day period 1 = Weeks 1-4 * 28-day period 2 = Weeks 5-8 * 28-day period 3 = Weeks 9-12 * 28-day period 4 = Weeks 13-16 * 28-day period 5 = Weeks 17-20 * 28-day period 6 = Weeks 21-24
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Headache Severity
Subject 1 baseline (5 days)
|
6 score on a scale
Interval 4.0 to 7.0
|
—
|
|
Headache Severity
Subject 1 28-day period 6 (14 days)
|
4 score on a scale
Interval 2.0 to 7.0
|
—
|
|
Headache Severity
Subject 2 Baseline (5 days)
|
3 score on a scale
Interval 2.0 to 4.0
|
—
|
|
Headache Severity
Subject 2 28-day period 6 (3 days)
|
4 score on a scale
Interval 2.0 to 6.0
|
—
|
|
Headache Severity
Subject 3 Baseline (7 days)
|
—
|
4 score on a scale
Interval 2.0 to 5.0
|
|
Headache Severity
Subject 3 28-day period 6 (9 days)
|
—
|
8 score on a scale
Interval 3.0 to 8.0
|
|
Headache Severity
Subject 4 Baseline (5 days)
|
5 score on a scale
Interval 3.0 to 7.0
|
—
|
|
Headache Severity
Subject 4 28-day period 4 (11 days)
|
7 score on a scale
Interval 6.0 to 8.0
|
—
|
|
Headache Severity
Subject 5 Baseline (1 day)
|
NA score on a scale
Data were collected on 1 day, therefore the baseline value was not valid
|
—
|
|
Headache Severity
Subject 5 28-day period 4 (2 days)
|
3 score on a scale
Interval 3.0 to 3.0
|
—
|
|
Headache Severity
Subject 6 Baseline (3 days)
|
—
|
NA score on a scale
Data were collected on 3 days, therefore the baseline value was not valid
|
|
Headache Severity
Subject 6 28-day period 2 (5 days)
|
—
|
2 score on a scale
Interval 2.0 to 9.0
|
|
Headache Severity
Subject 7 28-day period 4 (4 days)
|
—
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Headache Severity
Subject 8 Baseline (6 days)
|
—
|
4.5 score on a scale
Interval 3.0 to 6.0
|
|
Headache Severity
Subject 8 28-day period 2 (8 days)
|
—
|
7 score on a scale
Interval 6.0 to 9.0
|
|
Headache Severity
Subject 9 Baseline (5 days)
|
4 score on a scale
Interval 3.0 to 8.0
|
—
|
|
Headache Severity
Subject 9 28-day period 6 (11 days)
|
1 score on a scale
Interval 1.0 to 2.0
|
—
|
|
Headache Severity
Subject 10 Baseline (5 days)
|
7 score on a scale
Interval 7.0 to 8.0
|
—
|
|
Headache Severity
Subject 10 28-day period 4 (8 days)
|
6 score on a scale
Interval 3.0 to 7.0
|
—
|
|
Headache Severity
Subject 11 Baseline (5 days)
|
—
|
5 score on a scale
Interval 4.0 to 8.0
|
|
Headache Severity
Subject 11 28-day period 4 (3 days)
|
—
|
4 score on a scale
Interval 2.0 to 4.0
|
|
Headache Severity
Subject 12 Baseline (4 days)
|
NA score on a scale
Data were collected on 4 days, therefore the baseline value was not valid
|
—
|
|
Headache Severity
Subject 12 28-day period 1 (25 days)
|
6 score on a scale
Interval 3.0 to 9.0
|
—
|
|
Headache Severity
Subject 13 Baseline (6 days)
|
—
|
4.5 score on a scale
Interval 3.0 to 7.0
|
|
Headache Severity
Subject 13 28-day period 4 (2 days)
|
—
|
4 score on a scale
Interval 3.0 to 5.0
|
|
Headache Severity
Subject 14 28-day period 3 (1 day)
|
3 score on a scale
Interval 3.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data presented represents collected data from individual subjects. For anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. The number of days on which analgesic use were collected for each subject during the 7-day baseline and the last 28-day periods are provided in parentheses in row titles.
Number of days recorded in a 28-day window, where at least one dose of an acute headache analgesic was recorded. The baseline acute headache analgesic use was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days had to be recorded by the subject to obtain a valid baseline value. The number of acute headache analgesic use days was linearly scaled for each subject to give the number of acute headache analgesic use days during the baseline period and the last 28-day period during which headache data were collected on more than 7 days for each subject prior to study completion or discontinuation. * 28-day period 1 = Weeks 1-4 * 28-day period 2 = Weeks 5-8 * 28-day period 3 = Weeks 9-12 * 28-day period 4 = Weeks 13-16 * 28-day period 5 = Weeks 17-20 * 28-day period 6 = Weeks 21-24
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 1 Baseline (5 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 1 28-day period 6 (14 days)
|
6 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 2 Baseline (5 days)
|
16.8 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 2 28-day period 6 (3 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 3 Baseline (7 days)
|
—
|
4 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 3 28-day period 6 (9 days)
|
—
|
24.89 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 4 Baseline (5 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 4 28-day period 4 (11 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 5 Baseline (1 day)
|
NA Acute headache analgesics days per month
Data were collected on 1 day, therefore the baseline value was not valid
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 5 28-day period 4 (2 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 6 Baseline (3 days)
|
—
|
NA Acute headache analgesics days per month
Data were collected on 3 days, therefore the baseline value was not valid
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 6 28-day period 2 (5 days)
|
—
|
11.2 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 7 28-day period 4 (4 days)
|
—
|
0 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 8 Baseline (6 days)
|
—
|
0 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 8 28-day period 2 (8 days)
|
—
|
10.5 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 9 Baseline (5 days)
|
16.8 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 9 28-day period 6 (11 days)
|
0 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 10 Baseline (5 days)
|
11.2 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 10 28-day period 4 (8 days)
|
14 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 11 Baseline (5 days)
|
—
|
5.6 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 11 28-day period 4 (3 days)
|
—
|
0 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 12 Baseline (4 days)
|
NA Acute headache analgesics days per month
Data were collected on 4 days, therefore the baseline value was not valid
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 12 28-day period 1 (25 days)
|
13.44 Acute headache analgesics days per month
|
—
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 13 Baseline (6 days)
|
—
|
9.333 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 13 28-day period 4 (2 days)
|
—
|
14 Acute headache analgesics days per month
|
|
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Subject 14 28-day period 3 (1 day)
|
0 Acute headache analgesics days per month
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Data were not collected from subjects with qualifying study eyes for this endpoint.
Corrected visual acuity will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart, with a range of -0.3 to 1.00, where a lower score indicates better visual acuity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Treatment failure is defined as the initiation of either medical therapy or a surgical intervention to lower ICP during the study.
Outcome measures
| Measure |
Presendin
n=8 Participants
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 Participants
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
|---|---|---|
|
Number of Patients With Treatment Failure
Treatment failure suspected
|
0 participants
|
1 participants
|
|
Number of Patients With Treatment Failure
Treatment failure confirmed
|
0 participants
|
0 participants
|
Adverse Events
Presendin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
All Subjects Pre-treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Presendin
n=8 participants at risk
2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
Placebo
n=6 participants at risk
Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
|
All Subjects Pre-treatment
n=14 participants at risk
All subjects after signing the informed consent form and before being assigned to treatment groups or the start of dosing of the drug product
|
|---|---|---|---|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
COVID-19
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site mass
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site bruising
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site hypersensitivity
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site indentation
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site pain
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site pruritus
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site rash
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site swelling
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Abdominal abscess
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Otitis externa
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Investigations
Weight decreased
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/14 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
Infections and infestations
Pertussis
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
0.00%
0/6 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over a period of up to 30 weeks, from the signing of the informed consent form to the end of the follow-up period.
Adverse events reported from the signing of the informed consent form to the start of dosing of the drug product (active or placebo) are reported for the "All subjects pre-treatment group". Treatment-emergent adverse events (adverse events with an onset after the start of dosing of the drug product \[active or placebo\] or an event with an onset before dosing but that worsened in severity after the start of dosing) are reported for the "Placebo" and "Presendin" groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the Investigator wishes to publish anything related to the trial, then they must provide the Sponsor with the draft publication and allow them no less than 30 days to review the document. The Investigator cannot publish without written authorisation from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER