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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

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ClinicalTrials.gov Identifier: NCT03037203
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 31, 2017
Last Update Posted Date August 29, 2018
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 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03037203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Assess the effect of JZP110 on the Epworth Sleepiness Scale (ESS) score compared to baseline vs. placebo [ Time Frame: Weekly through week 4 ]
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 Not Provided
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: June 29, 2018)
60
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 August 2018

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