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

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.

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. Baseline ESS score >10.

4. Baseline mean sleep latency of ≤20 minutes on the MWT.

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. Prior or documented history of moderate or severe obstructive sleep apnea (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.

Principal Investigator

Rajesh Pahwa, MD

Study Contact

Jazz Pharmaceuticals, 650-496-3777

Estimated Completion Date

Sunday, April 1, 2018

ClinicalTrials.gov #

NCT03037203
02/28/2018