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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease; Excessive Sleepiness

Treatments: Other: Placebo; Drug: JZP-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT03037203

JZP166-201

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 3 patient groups, including a placebo group

Arm A

Experimental group

Description:

JZP-110 and Placebo

Treatment:

Other: Placebo

Drug: JZP-110

Arm B

Experimental group

Description:

JZP-110 and Placebo

Treatment:

Other: Placebo

Drug: JZP-110

Arm C

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo