Trial · NCT03037203

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

NCT03037203, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2020-01-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03037203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03037203

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03037203
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Excessive Sleepiness, Parkinson Disease
Interventions: JZP-110, Placebo
First posted: 2017-01-31
Last updated: 2020-01-09
Results first posted: 2020-01-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	Up to Day 35
Secondary	Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	Baseline to Weeks 1, 2, 3, and 4	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.
Other	Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)	Baseline to Weeks 1, 2, 3, and 4	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	Up to Day 35	The Safety population includes all subjects who received at least one dose of study drug	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	Baseline to Weeks 1, 2, 3, and 4	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.	score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)	Baseline to Weeks 1, 2, 3, and 4	The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).	minutes	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	JZP-110 75mg	1		Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	JZP-110 150mg	2		Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	JZP-110 300mg	0		Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	Placebo	0		Participants
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	JZP-110 75mg	-4.82	Standard Error 0.67	score on a scale
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	JZP-110 150mg	-5.04	Standard Error 0.70	score on a scale
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	JZP-110 300mg	-5.72	Standard Error 0.68	score on a scale
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	Placebo	-4.78	Standard Error 0.58	score on a scale
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)	JZP-110 75mg	0.4289	Standard Error 2.1254	minutes
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)	JZP-110 150mg	2.6721	Standard Error 2.1961	minutes

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment Sequence A	28
Overall Study	STARTED	Treatment Sequence B	28
Overall Study	STARTED	Treatment Sequence C	10
Overall Study	COMPLETED	Treatment Sequence A	27
Overall Study	COMPLETED	Treatment Sequence B	26
Overall Study	COMPLETED	Treatment Sequence C	9
Overall Study	NOT COMPLETED	Treatment Sequence A	1
Overall Study	NOT COMPLETED	Treatment Sequence B	2
Overall Study	NOT COMPLETED	Treatment Sequence C	1

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	JZP-110 75 mg	2	56
other	Nausea	Gastrointestinal disorders	JZP-110 150 mg	2	55
other	Nausea	Gastrointestinal disorders	JZP-110 300 mg	3	54
other	Nausea	Gastrointestinal disorders	Placebo	0	64
other	Dizziness	Nervous system disorders	JZP-110 75 mg	3	56
other	Dizziness	Nervous system disorders	JZP-110 150 mg	0	55
other	Dizziness	Nervous system disorders	JZP-110 300 mg	1	54
other	Dizziness	Nervous system disorders	Placebo	0	64
other	Headache	Nervous system disorders	JZP-110 75 mg	1	56
other	Headache	Nervous system disorders	JZP-110 150 mg	3	55

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	JZP-110 75 mg	0	56
Total, all-cause mortality	JZP-110 150 mg	0	55
Total, all-cause mortality	JZP-110 300 mg	0	54
Total, all-cause mortality	Placebo	0	64
Total, other adverse events	JZP-110 75 mg	4	56
Total, other adverse events	JZP-110 150 mg	5	55
Total, other adverse events	JZP-110 300 mg	4	54
Total, other adverse events	Placebo	0	64
Total, serious adverse events	JZP-110 75 mg	0	56
Total, serious adverse events	JZP-110 150 mg	0	55

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34191352	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT03037203/registered

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