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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

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ClinicalTrials.gov Identifier: NCT03037203
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Excessive Sleepiness
Parkinson Disease
Interventions Drug: JZP-110
Other: Placebo
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence A Treatment Sequence B Treatment Sequence C
Hide Arm/Group Description 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. 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. Subjects in Treatment Sequence C were assigned Placebo for each Period.
Period Title: Overall Study
Started 28 28 10
Completed 27 26 9
Not Completed 1 2 1
Arm/Group Title Treatment Sequence A Treatment Sequence B Treatment Sequence C Total
Hide Arm/Group Description 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. 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. Subjects in Treatment Sequence C were assigned Placebo for each Period. Total of all reporting groups
Overall Number of Baseline Participants 28 28 10 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 10 participants 66 participants
65.9  (7.64) 62.9  (8.75) 65.4  (9.75) 64.6  (8.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 10 participants 66 participants
Female
10
  35.7%
6
  21.4%
5
  50.0%
21
  31.8%
Male
18
  64.3%
22
  78.6%
5
  50.0%
45
  68.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 10 participants 66 participants
American Indian or Alaska Native
0
   0.0%
1
   3.6%
0
   0.0%
1
   1.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.6%
2
   7.1%
1
  10.0%
4
   6.1%
White
27
  96.4%
24
  85.7%
9
  90.0%
60
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.6%
0
   0.0%
1
   1.5%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Hide Description [Not Specified]
Time Frame Up to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population includes all subjects who received at least one dose of study drug
Arm/Group Title JZP-110 75mg JZP-110 150mg JZP-110 300mg Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 56 55 54 64
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.8%
2
   3.6%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Hide Description

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.

Time Frame Baseline to Weeks 1, 2, 3, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title JZP-110 75mg JZP-110 150mg JZP-110 300mg Placebo
Hide Arm/Group Description:
The JZP-110 75 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
The JZP-110 150 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
The JZP-110 300 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.
The Placebo group includes all subjects in the mITT population from Sequences A, B, and C - 64 subjects in total.
Overall Number of Participants Analyzed 55 55 55 64
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.82  (0.67) -5.04  (0.70) -5.72  (0.68) -4.78  (0.58)
3.Other Pre-specified Outcome
Title Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
Hide Description

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.

Time Frame Baseline to Weeks 1, 2, 3, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).
Arm/Group Title JZP-110 75mg JZP-110 150mg JZP-110 300mg Placebo
Hide Arm/Group Description:
The JZP-110 75 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
The JZP-110 150 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
The JZP-110 300 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.
The Placebo group includes all subjects in the mITT population in Group 1 from Sequences A, B, and C - 53 subjects in total.
Overall Number of Participants Analyzed 47 47 47 53
Least Squares Mean (Standard Error)
Unit of Measure: minutes
0.4289  (2.1254) 2.6721  (2.1961) 6.8133  (2.1351) 1.7670  (1.8479)
Time Frame Up to Day 35
Adverse Event Reporting Description The Safety population includes all subjects who received at least one dose of study drug
 
Arm/Group Title JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg Placebo
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%)   0/54 (0.00%)   0/64 (0.00%) 
Hide Serious Adverse Events
JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%)   1/54 (1.85%)   0/64 (0.00%) 
Renal and urinary disorders         
Haematuria  1  0/56 (0.00%)  0/55 (0.00%)  1/54 (1.85%)  0/64 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
JZP-110 75 mg JZP-110 150 mg JZP-110 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/56 (7.14%)   5/55 (9.09%)   4/54 (7.41%)   0/64 (0.00%) 
Gastrointestinal disorders         
Nausea  1  2/56 (3.57%)  2/55 (3.64%)  3/54 (5.56%)  0/64 (0.00%) 
Nervous system disorders         
Dizziness  1  3/56 (5.36%)  0/55 (0.00%)  1/54 (1.85%)  0/64 (0.00%) 
Headache  1  1/56 (1.79%)  3/55 (5.45%)  2/54 (3.70%)  0/64 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Disclosure & Transparency
Organization: Jazz Pharmaceuticals
Phone: 2159707145
EMail: ClinicalTrialDisclosure@JazzPharma.com
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03037203    
Other Study ID Numbers: JZP166-201
First Submitted: January 23, 2017
First Posted: January 31, 2017
Results First Submitted: August 16, 2019
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020