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

  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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		JZP-110 and Placebo
  • Drug: JZP-110
    75 mg, 150 mg, 300 mg
  • Other: Placebo
Experimental
Arm B 		JZP-110 and Placebo
  • Drug: JZP-110
    75 mg, 150 mg, 300 mg
  • Other: Placebo
Placebo Comparator
Arm C 		Placebo
  • Other: Placebo

More Details

Status
Completed
Sponsor
Jazz Pharmaceuticals

Study Contact