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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Jazz Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03037203
First received: January 23, 2017
Last updated: February 13, 2017
Last verified: February 2017
  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.

Condition Intervention Phase
Excessive Sleepiness
Parkinson Disease
Drug: JZP-110
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Safety as assessed by the incidence of treatment emergent adverse events up until the last visit at week 5 [ Time Frame: Weekly through week 5 ]

Secondary Outcome Measures:
  • Assess the effect of JZP110 on the Maintenance of Wakefulness Test (MWT) compared to baseline vs. placebo [ Time Frame: Weekly through week 4 ]
  • Assess the effect of JZP110 on the Epworth Sleepiness Scale (ESS) score compared to baseline vs. placebo [ Time Frame: Weekly through week 4] ]

Estimated Enrollment: 49
Study Start Date: January 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
JZP-110 and Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg
Other: Placebo
Experimental: Arm B
JZP-110 and Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg
Other: Placebo
Placebo Comparator: Arm C
Placebo
Other: Placebo

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03037203

Contacts
Contact: Jazz Pharmaceuticals 650-496-3777

Locations
United States, California
Pacific Research Network, Inc Recruiting
San Diego, California, United States, 92103
Principal Investigator: Stephen Thein         
United States, Georgia
NeuroTrials Research, Inc. Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Russell Rosenberg, MD         
United States, Maryland
Center for Sleep & Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Principal Investigator: Helene Emsellem         
United States, South Carolina
SleepMed of South Carolina Recruiting
Columbia, South Carolina, United States, 29201
Principal Investigator: Richard Bogan         
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Study Director: Millie Gottwald, PharmD Jazz Pharmaceuticals
  More Information

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03037203     History of Changes
Other Study ID Numbers: JZP166-201
Study First Received: January 23, 2017
Last Updated: February 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Disorders of Excessive Somnolence
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017