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
Purpose
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.
Conditions
- Excessive Sleepiness
- Parkinson Disease
Eligibility
- Eligible Ages
- Between 35 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Arm A |
JZP-110 and Placebo |
|
Experimental Arm B |
JZP-110 and Placebo |
|
Placebo Comparator Arm C |
Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals