Parkinson Disease Clinical Trial
Official title:
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
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 |
Verified date | January 2020 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States,
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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