Trial Outcomes & Findings for A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness (NCT NCT03037203)
NCT ID: NCT03037203
Last Updated: 2020-01-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to Day 35
Results posted on
2020-01-09
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A
Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.
|
Treatment Sequence B
Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.
|
Treatment Sequence C
Subjects in Treatment Sequence C were assigned Placebo for each Period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
10
|
|
Overall Study
COMPLETED
|
27
|
26
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Baseline characteristics by cohort
| Measure |
Treatment Sequence A
n=28 Participants
Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.
|
Treatment Sequence B
n=28 Participants
Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.
|
Treatment Sequence C
n=10 Participants
Subjects in Treatment Sequence C were assigned Placebo for each Period.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.75 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 8.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
60 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 35Population: The Safety population includes all subjects who received at least one dose of study drug
Outcome measures
| Measure |
JZP-110 75mg
n=56 Participants
The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
|
JZP-110 150mg
n=55 Participants
The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
|
JZP-110 300mg
n=54 Participants
The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
|
Placebo
n=64 Participants
The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 3, and 4Population: The modified Intent-to-Treat population is defined as all randomized subjects who took at least one dose of study drug and have a Baseline and at least one post-Baseline efficacy assessment. Two subjects who did not have at least one post-baseline efficacy data were excluded from the mITT Population, resulting in a total of 64 subjects.
Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
Outcome measures
| Measure |
JZP-110 75mg
n=55 Participants
The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
|
JZP-110 150mg
n=55 Participants
The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
|
JZP-110 300mg
n=55 Participants
The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
|
Placebo
n=64 Participants
The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
|
|---|---|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
|
-4.82 score on a scale
Standard Error 0.67
|
-5.04 score on a scale
Standard Error 0.70
|
-5.72 score on a scale
Standard Error 0.68
|
-4.78 score on a scale
Standard Error 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Weeks 1, 2, 3, and 4Population: The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).
Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.
Outcome measures
| Measure |
JZP-110 75mg
n=47 Participants
The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
|
JZP-110 150mg
n=47 Participants
The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
|
JZP-110 300mg
n=47 Participants
The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
|
Placebo
n=53 Participants
The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
|
|---|---|---|---|---|
|
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
|
0.4289 minutes
Standard Error 2.1254
|
2.6721 minutes
Standard Error 2.1961
|
6.8133 minutes
Standard Error 2.1351
|
1.7670 minutes
Standard Error 1.8479
|
Adverse Events
JZP-110 75 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
JZP-110 150 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
JZP-110 300 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JZP-110 75 mg
n=56 participants at risk
The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
|
JZP-110 150 mg
n=55 participants at risk
The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
|
JZP-110 300 mg
n=54 participants at risk
The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
|
Placebo
n=64 participants at risk
The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/56 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/55 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
1.9%
1/54 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/64 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
Other adverse events
| Measure |
JZP-110 75 mg
n=56 participants at risk
The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.
|
JZP-110 150 mg
n=55 participants at risk
The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.
|
JZP-110 300 mg
n=54 participants at risk
The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.
|
Placebo
n=64 participants at risk
The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/56 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
3.6%
2/55 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
5.6%
3/54 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/64 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
5.4%
3/56 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/55 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
1.9%
1/54 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/64 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
5.5%
3/55 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
3.7%
2/54 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
0.00%
0/64 • Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
- Publication restrictions are in place
Restriction type: OTHER