Clinical trial NCT03037203: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Excessive Sleepiness
Parkinson Disease
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 66
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
timeFrame: Up to Day 35
Secondary outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
timeFrame: Baseline to Weeks 1, 2, 3, and 4
Other outcomes:
measure: Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
timeFrame: Baseline to Weeks 1, 2, 3, and 4
Locations:
city: Los Angeles
country: United States
facility: Southern California Institute For Respiratory Diseases, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center, PC
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami
country: United States
facility: QPS MRA (Miami Research Associates)
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Tampa
country: United States
facility: USF Health Byrd Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Chevy Chase
country: United States
facility: Center for Sleep & Wake Disorders
state: Maryland
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services, P.C.
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center - West Bloomfield
state: Michigan
city: Chesterfield
country: United States
facility: St. Lukes Hospital Medical Center
state: Missouri
city: Bronx
country: United States
facility: Montefiore Sleep-Wake Disorders Center
state: New York
city: Rochester
country: United States
facility: Strong Sleep Disorders Center
state: New York
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Parkinson's Disease Research Unit - Thomas Jefferson University
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Villages at Vanderbilt
state: Tennessee
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research - Sherman
state: Washington
Study officials:
affiliation: Jazz Pharmaceuticals
name: Millie Gottwald, PharmD
role: STUDY_DIRECTOR
References:
citation: Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, Gottwald MD, Steinerman JR, Jochelson P, Zomorodi K, Hauser RA. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Oct;36(10):2408-2412. doi: 10.1002/mds.28702. Epub 2021 Jun 30.