Clinical Trial Details

Overview

Research Study Summary

A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover 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

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CW ID: 224223
Date Last Changed: June 28, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
35 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Jazz Pharmaceuticals
Facility Type
Out-Patient

Eligibility

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.

More Info

Protocol Number: BN29739

Contact

Leigh Harrell
University of South Florida - Byrd Alzheimer's Institute
4001 Fletcher Ave.
Tampa, FL 33613
Phone: (813) 396-0768

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