Trial Outcomes & Findings for A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine (NCT NCT04153409)
NCT ID: NCT04153409
Last Updated: 2021-04-28
Results Overview
Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Results posted on
2021-04-28
Participant Flow
Participant milestones
| Measure |
LAT8881, Then Placebo
Subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity.
|
Placebo, Then LAT8881
Subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Baseline characteristics by cohort
| Measure |
LAT8881, Then Placebo
n=10 Participants
Subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity.
|
Placebo, Then LAT8881
n=11 Participants
Subjects took 2 placebo capsules at the onset of a migraine of moderate to severe intensity. After treatment of one migraine (or a maximum of 28 days), subjects took LAT8881 60 mg (2 capsules) at the onset of a migraine of moderate to severe intensity.
|
Total
n=21 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
38.8 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 13.64 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 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
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dosePopulation: Per protocol population
Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity.
Outcome measures
| Measure |
Active
n=16 Participants
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
LAT8881: Two 30 mg capsules of LAT8881
|
Placebo
n=17 Participants
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Placebo: Two capsules of placebo
|
|---|---|---|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 0.5 hours
|
0 score on a scale
Standard Deviation 1.10
|
0.2 score on a scale
Standard Deviation 1.33
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 1 hour
|
-0.8 score on a scale
Standard Deviation 1.83
|
-0.2 score on a scale
Standard Deviation 1.68
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 1.5 hours
|
-0.9 score on a scale
Standard Deviation 2.36
|
-0.5 score on a scale
Standard Deviation 1.84
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 2 hours
|
-1.8 score on a scale
Standard Deviation 3.12
|
-0.8 score on a scale
Standard Deviation 2.63
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 4 hours
|
-2.7 score on a scale
Standard Deviation 2.96
|
-2.2 score on a scale
Standard Deviation 3.56
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 8 hours
|
-4.6 score on a scale
Standard Deviation 2.31
|
-3.7 score on a scale
Standard Deviation 3.39
|
|
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Change from baseline at 24 hours
|
-5.8 score on a scale
Standard Deviation 1.87
|
-5.6 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dosePopulation: Per protocol population
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity
Outcome measures
| Measure |
Active
n=16 Participants
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
LAT8881: Two 30 mg capsules of LAT8881
|
Placebo
n=17 Participants
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Placebo: Two capsules of placebo
|
|---|---|---|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 0.5 hours
|
-0.3 score on a scale
Standard Deviation 2.24
|
-0.1 score on a scale
Standard Deviation 1.05
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 1 hour
|
-0.9 score on a scale
Standard Deviation 2.87
|
-0.6 score on a scale
Standard Deviation 1.28
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 1.5 hours
|
-1.0 score on a scale
Standard Deviation 3.93
|
-1.0 score on a scale
Standard Deviation 1.70
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 2 hours
|
-1.6 score on a scale
Standard Deviation 4.02
|
-1.0 score on a scale
Standard Deviation 2.00
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 4 hours
|
-2.1 score on a scale
Standard Deviation 4.30
|
-2.1 score on a scale
Standard Deviation 2.41
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 8 hours
|
-4.3 score on a scale
Standard Deviation 3.32
|
-2.8 score on a scale
Standard Deviation 3.60
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in nausea at 24 hours
|
-4.9 score on a scale
Standard Deviation 3.04
|
-3.6 score on a scale
Standard Deviation 2.89
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 0.5 hours
|
-0.2 score on a scale
Standard Deviation 0.75
|
0.2 score on a scale
Standard Deviation 1.07
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 1 hour
|
-0.9 score on a scale
Standard Deviation 1.91
|
0.0 score on a scale
Standard Deviation 1.46
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 1.5 hours
|
-0.8 score on a scale
Standard Deviation 2.08
|
-0.8 score on a scale
Standard Deviation 2.59
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 2 hours
|
-1.3 score on a scale
Standard Deviation 2.52
|
-0.9 score on a scale
Standard Deviation 2.93
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 4 hours
|
-2.1 score on a scale
Standard Deviation 2.70
|
-2.4 score on a scale
Standard Deviation 3.68
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 8 hours
|
-3.8 score on a scale
Standard Deviation 2.52
|
-3.6 score on a scale
Standard Deviation 3.54
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in photophobia at 24 hours
|
-4.6 score on a scale
Standard Deviation 2.39
|
-4.4 score on a scale
Standard Deviation 3.12
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 0.5 hours
|
0.1 score on a scale
Standard Deviation 0.89
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-0.2 score on a scale
Standard Deviation 1.68
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 1 hour
|
-0.6 score on a scale
Standard Deviation 2.09
|
-0.4 score on a scale
Standard Deviation 1.73
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 1.5 hours
|
-0.5 score on a scale
Standard Deviation 2.19
|
-0.8 score on a scale
Standard Deviation 1.95
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 2 hours
|
-0.2 score on a scale
Standard Deviation 2.61
|
-0.7 score on a scale
Standard Deviation 2.31
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 4 hours
|
-0.6 score on a scale
Standard Deviation 2.53
|
-1.8 score on a scale
Standard Deviation 3.05
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 8 hours
|
-1.8 score on a scale
Standard Deviation 2.48
|
-2.3 score on a scale
Standard Deviation 2.91
|
|
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Change in phonophobia at 24 hours
|
-2.3 score on a scale
Standard Deviation 2.35
|
-2.6 score on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dosePopulation: Per protocol population
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity.
Outcome measures
| Measure |
Active
n=16 Participants
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
LAT8881: Two 30 mg capsules of LAT8881
|
Placebo
n=17 Participants
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Placebo: Two capsules of placebo
|
|---|---|---|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 0.5 hours
|
-0.5 score on a scale
Standard Deviation 2.03
|
-0.1 score on a scale
Standard Deviation 1.60
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 1 hour
|
-1.1 score on a scale
Standard Deviation 2.33
|
-0.6 score on a scale
Standard Deviation 2.06
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from base at 1.5 hours
|
-1.2 score on a scale
Standard Deviation 3.06
|
-1.2 score on a scale
Standard Deviation 2.86
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 2 hours
|
-1.5 score on a scale
Standard Deviation 3.46
|
-1.5 score on a scale
Standard Deviation 3.16
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 4 hours
|
-2.6 score on a scale
Standard Deviation 3.58
|
-2.8 score on a scale
Standard Deviation 3.68
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 8 hours
|
-3.9 score on a scale
Standard Deviation 2.69
|
-4.0 score on a scale
Standard Deviation 3.26
|
|
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Change from baseline at 24 hours
|
-5.2 score on a scale
Standard Deviation 2.01
|
-5.0 score on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dosePopulation: Per protocol population
Defined as having no migraine headache pain
Outcome measures
| Measure |
Active
n=16 Participants
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
LAT8881: Two 30 mg capsules of LAT8881
|
Placebo
n=17 Participants
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Placebo: Two capsules of placebo
|
|---|---|---|
|
The Percentage of Subjects Achieving "no Headache Pain"
0.5 hours
|
0 Participants
|
0 Participants
|
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The Percentage of Subjects Achieving "no Headache Pain"
1 hour
|
0 Participants
|
0 Participants
|
|
The Percentage of Subjects Achieving "no Headache Pain"
1.5 hours
|
0 Participants
|
0 Participants
|
|
The Percentage of Subjects Achieving "no Headache Pain"
2 hours
|
2 Participants
|
0 Participants
|
|
The Percentage of Subjects Achieving "no Headache Pain"
4 hours
|
2 Participants
|
2 Participants
|
|
The Percentage of Subjects Achieving "no Headache Pain"
8 hours
|
6 Participants
|
6 Participants
|
|
The Percentage of Subjects Achieving "no Headache Pain"
24 hours
|
11 Participants
|
12 Participants
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=17 participants at risk
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
LAT8881: Two 30 mg capsules of LAT8881
|
Placebo
n=17 participants at risk
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Placebo: Two capsules of placebo
|
|---|---|---|
|
Infections and infestations
Otitis externa
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
|
Investigations
C-reactive protein increased
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
0.00%
0/17 • Adverse event data was collected from the first dose until the end of study visit, approximately 64 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Except for legal reasons, the investigator will not reveal the result of the study to a third party without a mutual agreement about the analysis and interpretation of the data with the sponsor.
- Publication restrictions are in place
Restriction type: OTHER