Brief Summary
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
Brief 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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Excessive Sleepiness
Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
Exclusion Criteria:
1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy \[MSA\], or dementia with Lewy bodies \[DLB\]).
2. Usual nightly time in bed of \<6 hours, including the night before the Baseline visit.
3. Untreated or inadequately treated moderate to severe OSA.
4. Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
Exclusion Criteria:
1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy \[MSA\], or dementia with Lewy bodies \[DLB\]).
2. Usual nightly time in bed of \<6 hours, including the night before the Baseline visit.
3. Untreated or inadequately treated moderate to severe OSA.
4. Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
Inclusion Criteria
Inclusion Criteria:
1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
35 Years
NCT Id
NCT03037203
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
JZP166-201
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover 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
Primary Outcomes
Outcome Measure
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Outcome Time Frame
Up to Day 35
Secondary Outcomes
Outcome 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.
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 Time Frame
Baseline to Weeks 1, 2, 3, and 4
Outcome Measure
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
35
Investigators
Investigator Type
Principal Investigator
Investigator Name
Renee Monderer
Investigator Email
rmondere@montefiore.org
Investigator Phone