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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037203
Other study ID # JZP166-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2017
Est. completion date August 2018

Study information

Verified date January 2020
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 35 Years to 80 Years
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. 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


Related Conditions & MeSH terms


Intervention

Drug:
JZP-110
75 mg, 150 mg, 300 mg
Other:
Placebo


Locations

Country Name City State
United States Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida
United States Alpine Clinical Research Center Boulder Colorado
United States PAB Clinical Research Brandon Florida
United States Montefiore Sleep-Wake Disorders Center Bronx New York
United States St. Lukes Hospital Medical Center Chesterfield Missouri
United States Center for Sleep & Wake Disorders Chevy Chase Maryland
United States Rush University Medical Center Chicago Illinois
United States SleepMed of South Carolina Columbia South Carolina
United States Rocky Mountain Movement Disorders Center, PC Englewood Colorado
United States QUEST Research Institute Farmington Hills Michigan
United States MD Clinical Hallandale Beach Florida
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States Evergreen Hospital Medical Center Kirkland Washington
United States Southern California Institute For Respiratory Diseases, Inc. Los Angeles California
United States QPS MRA (Miami Research Associates) Miami Florida
United States Villages at Vanderbilt Nashville Tennessee
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Bioclinica Research Orlando Florida
United States Parkinson's Disease Research Unit - Thomas Jefferson University Philadelphia Pennsylvania
United States Strong Sleep Disorders Center Rochester New York
United States Pacific Research Network, Inc San Diego California
United States Premier Clinical Research - Sherman Spokane Washington
United States Clinical Neurophysiology Services, P.C. Sterling Heights Michigan
United States USF Health Byrd Institute Tampa Florida
United States Henry Ford Medical Center - West Bloomfield West Bloomfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT) Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).
The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.
Baseline to Weeks 1, 2, 3, and 4
Primary Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation Up to Day 35
Secondary Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
Baseline to Weeks 1, 2, 3, and 4
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