Trial Outcomes & Findings for A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia (NCT NCT04435431)
NCT ID: NCT04435431
Last Updated: 2024-03-06
Results Overview
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. ON time without troublesome dyskinesia measures time when the medication is working without causing troublesome dyskinesia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Baseline to end of treatment (week 12)
Results posted on
2024-03-06
Participant Flow
Participant milestones
| Measure |
Mesdopetam 2.5 mg
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
38
|
39
|
|
Overall Study
COMPLETED
|
32
|
31
|
29
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
Baseline characteristics by cohort
| Measure |
Mesdopetam 2.5 mg
n=40 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=38 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=38 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=39 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
64.9 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
8 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
17 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
Serbia
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Height at Screening
|
167.8 cm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
167.0 cm
STANDARD_DEVIATION 8.8 • n=7 Participants
|
167.8 cm
STANDARD_DEVIATION 8.5 • n=5 Participants
|
165.7 cm
STANDARD_DEVIATION 9.3 • n=4 Participants
|
167.1 cm
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Weight at Screening
|
76.9 kg
STANDARD_DEVIATION 15.0 • n=5 Participants
|
73.1 kg
STANDARD_DEVIATION 14.8 • n=7 Participants
|
73.1 kg
STANDARD_DEVIATION 13.7 • n=5 Participants
|
70.3 kg
STANDARD_DEVIATION 17.3 • n=4 Participants
|
73.4 kg
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
BMI at Screening
|
27.1 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 6.1 • n=4 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 5.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (week 12)Population: Full Analysis Set
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. ON time without troublesome dyskinesia measures time when the medication is working without causing troublesome dyskinesia.
Outcome measures
| Measure |
Mesdopetam 2.5 mg
n=35 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=35 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=33 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=37 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Change in Average Daily Hours of ON-time Without Troublesome Dyskinesia With Mesdopetam Compared to Placebo as Assessed With 24-hour Patient Home Diaries From Baseline to End of Treatment.
|
1.211 hours per day
Standard Error 0.4895
|
1.737 hours per day
Standard Error 0.5028
|
2.233 hours per day
Standard Error 0.5278
|
1.985 hours per day
Standard Error 0.4776
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (week 12)Population: Full Analysis Set
The scoring range is 0-88, where higher score means more dyskinesia.
Outcome measures
| Measure |
Mesdopetam 2.5 mg
n=35 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=35 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=33 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=37 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Change From Baseline in Mean Score of ON-phase Dyskinesia Assessed With the Sum Score of the Modified Unified Dyskinesia Rating Scale (UDysRS), Parts 1, 3 and 4, With Mesdopetam Compared to Placebo.
|
-11.5 Units on the scale
Standard Error 1.90
|
-9.3 Units on the scale
Standard Error 1.92
|
-12.0 Units on the scale
Standard Error 2.00
|
-5.8 Units on the scale
Standard Error 1.87
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (week 12)Population: Full Analysis Set
The scoring range is 0-60, where higher score means more disability associated with dyskinesia.
Outcome measures
| Measure |
Mesdopetam 2.5 mg
n=35 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=35 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=33 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=37 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Change From Baseline in Mean Score of Disability Associated With ON-phase Dyskinesia Assessed With the Sum Score of Parts 1b and 4 of the Unified Dyskinesia Rating Scale (UDysRS), With Mesdopetam Compared to Placebo.
|
-6.3 Units on the scale
Standard Error 1.27
|
-5.8 Units on the scale
Standard Error 1.28
|
-7.2 Units on the scale
Standard Error 1.33
|
-3.7 Units on the scale
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (week 12)Population: Full Analysis Set
This scale is a patient reported outcome measure assessing motor aspects of experiences of daily living. Minimum score is 0 and maximum score is 52. A higher score means more Parkinson's disease motor symptoms.
Outcome measures
| Measure |
Mesdopetam 2.5 mg
n=35 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=35 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=33 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=37 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Change From Baseline in Mean Score of Motor Symptoms of PD Assessed With MDS-UPDRS Total Score of Part 2 (M-EDL) (With Mesdopetam Compared to Placebo)
|
-0.9 Total Score
Standard Error 0.78
|
-0.7 Total Score
Standard Error 0.79
|
0.0 Total Score
Standard Error 0.82
|
0.0 Total Score
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (week 12)Population: Full Analysis Set
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. OFF time means time means daily time spent when the medication is not working.
Outcome measures
| Measure |
Mesdopetam 2.5 mg
n=35 Participants
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=35 Participants
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=33 Participants
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=37 Participants
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Change From Baseline in Average Daily Hours of OFF-time (With Mesdopetam Compared to Placebo).
|
-0.029 hours per day
Standard Error 0.3431
|
-0.324 hours per day
Standard Error 0.3522
|
-0.768 hours per day
Standard Error 0.3689
|
-0.069 hours per day
Standard Error 0.3352
|
Adverse Events
Mesdopetam 2.5 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Mesdopetam 5 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Mesdopetam 7.5 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesdopetam 2.5 mg
n=40 participants at risk
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=38 participants at risk
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=38 participants at risk
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=39 participants at risk
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Immune system disorders
Pneumonia
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Cardiac disorders
Arrhytmia
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Cardiac disorders
Cardiac failure
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/39 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
General disorders
Sudden death
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/39 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
1/40 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/39 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/40 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/38 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/39 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
Other adverse events
| Measure |
Mesdopetam 2.5 mg
n=40 participants at risk
Mesdopetam capsule (2.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 5 mg
n=38 participants at risk
Mesdopetam capsule (5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Mesdopetam 7.5 mg
n=38 participants at risk
Mesdopetam capsule (7.5 mg), 1 capsule b.i.d. for 84 days.
Mesdopetam: Oral use
|
Placebo
n=39 participants at risk
Placebo capsule, 1 capsule b.i.d. for 84 days
Placebo: Oral use
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
5.0%
2/40 • Number of events 3 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
10.5%
4/38 • Number of events 5 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
5.3%
2/38 • Number of events 5 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
0.00%
0/39 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Nervous system disorders
Parkinsonism
|
2.5%
1/40 • Number of events 2 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
5.3%
2/38 • Number of events 2 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 2 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
10.3%
4/39 • Number of events 4 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Nervous system disorders
Dyskinesia
|
10.0%
4/40 • Number of events 4 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
7.7%
3/39 • Number of events 4 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40 • Number of events 5 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
2.6%
1/38 • Number of events 1 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
5.3%
2/38 • Number of events 2 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
5.1%
2/39 • Number of events 2 • Collection of AEs started after the patient signed the ICF (Screening visit) and continued until the last follow-up assessment (End of Study visit/Early Withdrawal visit) in total up to 21 weeks.
|
Additional Information
Joakim Tedroff, Chief Medical Officer
Integrative Research Laboratories Sweden AB
Phone: +46707601691
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Protection of potential intellectual property of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER