Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037203
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 31, 2017
Results First Submitted Date  ICMJE August 16, 2019
Results First Posted Date  ICMJE January 9, 2020
Last Update Posted Date January 9, 2020
Study Start Date  ICMJE January 2017
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation [ Time Frame: Up to Day 35 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score [ Time Frame: Baseline to Weeks 1, 2, 3, and 4 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • 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] ]
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2020)
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline to Weeks 1, 2, 3, and 4 ]
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Excessive Sleepiness
  • Parkinson Disease
Intervention  ICMJE
  • Drug: JZP-110
    75 mg, 150 mg, 300 mg
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Arm A
    JZP-110 and Placebo
    Interventions:
    • Drug: JZP-110
    • Other: Placebo
  • Experimental: Arm B
    JZP-110 and Placebo
    Interventions:
    • Drug: JZP-110
    • Other: Placebo
  • Placebo Comparator: Arm C
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2020)
66
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2017)
49
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03037203
Other Study ID Numbers  ICMJE JZP166-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Millie Gottwald, PharmD Jazz Pharmaceuticals
PRS Account Jazz Pharmaceuticals
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP