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.
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.
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.