Trial Outcomes & Findings for Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia (NCT NCT03368170)
NCT ID: NCT03368170
Last Updated: 2022-03-31
Results Overview
The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
COMPLETED
PHASE2
75 participants
Baseline and 4 weeks
2022-03-31
Participant Flow
The study was conducted as an outpatient trial and patients were identified from 20 sites across two countries. The first patient was enrolled 13 April 2018 and the last past completed 12 June 2019.
Patients completed two 24-hour diaries during run-in of which one had to be valid prior randomization.
Participant milestones
| Measure |
Mesdopetam
Mesdopetam capsule, 2.5 mg oral administration. Dose given twice daily (5 mg, 7.5 mg or 10 mg b.i.d.) The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated predefined dose, after which patients continued on this highest per patient tolerated dose for an additional two weeks.
|
Placebo
Matching placebo capsule, oral administration. Dose given twice daily.
The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated number of placebo capsules (1 capsule x 4), after which patients continued on this highest tolerated dose for an additional two weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Mesdopetam
Mesdopetam capsule, 2.5 mg oral administration. Dose given twice daily (5 mg, 7.5 mg or 10 mg b.i.d.) The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated predefined dose, after which patients continued on this highest per patient tolerated dose for an additional two weeks.
|
Placebo
Matching placebo capsule, oral administration. Dose given twice daily.
The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated number of placebo capsules (1 capsule x 4), after which patients continued on this highest tolerated dose for an additional two weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
Baseline characteristics by cohort
| Measure |
Mesdopetam
n=39 Participants
Mesdopetam (IRL790): 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=36 Participants
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
67.7 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
66.6 years
STANDARD_DEVIATION 8.36 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Body Mass Index
|
26.6 kg/m^2
STANDARD_DEVIATION 7.2 • n=93 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=4 Participants
|
26 kg/m^2
STANDARD_DEVIATION 5.92 • n=27 Participants
|
|
Height
|
166.7 centimeters
STANDARD_DEVIATION 10.3 • n=93 Participants
|
169 centimeters
STANDARD_DEVIATION 9.4 • n=4 Participants
|
168 centimeters
STANDARD_DEVIATION 9.87 • n=27 Participants
|
|
Years with Parkinson's disease
|
10.7 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
10.7 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
10.7 years
STANDARD_DEVIATION 5.15 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).
The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
Outcome measures
| Measure |
Mesdopetam
n=36 Participants
Mesdopetam: 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=34 Participants
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
|---|---|---|
|
Unified Dyskinesia Rating Scale (UDysRS)
|
-4.2 score on a scale
Interval -7.3 to -1.0
|
-7.0 score on a scale
Interval -10.3 to -3.8
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).
Change in MDS-UPDRS sum score of questions 4.1 (Time spent with dyskinesias) and 4.2 (Functional impact of dyskinesias) in part IV from baseline to visit 4. Minimum score is 0 and maximum score is 8. A higher score means more dyskinesia.
Outcome measures
| Measure |
Mesdopetam
n=37 Participants
Mesdopetam: 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=35 Participants
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Question 4.1 and 4.2
|
-1.3 score on a scale
Interval -1.8 to 0.8
|
-0.6 score on a scale
Interval -1.1 to 0.1
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).
Change in MDS-UPDRS sum score of parts II+III (Motor aspects of Experiences of Daily living + Motor Examination) from baseline to visit 4. Minimum value is 0 and maximum value is 124. Higher score mean a worse outcome.
Outcome measures
| Measure |
Mesdopetam
n=37 Participants
Mesdopetam: 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=35 Participants
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II and III
|
-3.0 score on a scale
Interval -6.5 to 0.6
|
-2.2 score on a scale
Interval -5.9 to 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Run-in and 4 weeksPopulation: Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).
Change in ON-time with troublesome dyskinesia as assessed by patient completed 24-hour diaries, from run-in to visit 4. This is a self administered diary where patients assess their motor state every half hour during 24 hours. The different motor states assessed: ON, ON with troublesome dyskinesia, OFF and asleep.
Outcome measures
| Measure |
Mesdopetam
n=37 Participants
Mesdopetam: 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=34 Participants
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
|---|---|---|
|
Change in Daily Hours Spent in ON-time With Troublesome Dyskinesia as Assessed by 24-hour Patient Diaries
|
-3.3 daily hours
Interval -4.3 to -2.4
|
-1.7 daily hours
Interval -2.8 to -0.7
|
Adverse Events
Mesdopetam
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mesdopetam
n=39 participants at risk
Mesdopetam (IRL790): 2.5 mg white hard HPMC capsule, oral administration
|
Placebo
n=36 participants at risk
Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • 5 weeks
|
8.3%
3/36 • 5 weeks
|
|
Nervous system disorders
Dyskinesia
|
10.3%
4/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Nervous system disorders
Freezing phenomenon
|
2.6%
1/39 • 5 weeks
|
11.1%
4/36 • 5 weeks
|
|
Nervous system disorders
Headache
|
12.8%
5/39 • 5 weeks
|
13.9%
5/36 • 5 weeks
|
|
Nervous system disorders
On and off phenomenon
|
5.1%
2/39 • 5 weeks
|
2.8%
1/36 • 5 weeks
|
|
Nervous system disorders
Parkinsonism
|
23.1%
9/39 • 5 weeks
|
8.3%
3/36 • 5 weeks
|
|
General disorders
Fatigue
|
5.1%
2/39 • 5 weeks
|
25.0%
9/36 • 5 weeks
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Psychiatric disorders
Sleep disorder
|
7.7%
3/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal stiffness
|
2.6%
1/39 • 5 weeks
|
8.3%
3/36 • 5 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • 5 weeks
|
11.1%
4/36 • 5 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
10.3%
4/39 • 5 weeks
|
8.3%
3/36 • 5 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/39 • 5 weeks
|
5.6%
2/36 • 5 weeks
|
Additional Information
Joakim Tedroff/Chief Medical Officer
Integrative Research Laboratories AB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place