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Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy

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ClinicalTrials.gov Identifier: NCT02806908
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief Summary:
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.

Condition or disease Intervention/treatment Phase
Narcolepsy Excessive Sleepiness Drug: JZP-110 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Narcolepsy
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Once daily dosing
Drug: Placebo
Active Comparator: JZP-110
150 mg/day for first 3 days and 300 mg/day for next 4 days
Drug: JZP-110



Primary Outcome Measures :
  1. Standard deviation of lateral position (SDLP) [ Time Frame: At 2 hours post-dose (approximately at Tmax) ]
    Subject will be instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 km/hr. Deviation is measured by the vehicle's speed and lateral distance to the left lane line and will be continuously recorded.


Secondary Outcome Measures :
  1. Standard deviation of lateral position (SDLP) [ Time Frame: At 6 hours post-dose ]
  2. Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo [ Time Frame: At Days 7 and 14 ]
  3. Standard Deviation of Speed (SDS) [ Time Frame: At Days 7 and 14 ]
  4. Psychomotor Vigilance Test (PVT) number of lapses [ Time Frame: At Days 7 and 14 ]
    Reaction Time (RT) in milliseconds > 500 milliseconds

  5. Psychomotor Vigilance Test (OVT) mean reaction time [ Time Frame: At Days 7 and 14 ]
    In milliseconds

  6. Psychomotor Vigilance Test (PVT) inverse reaction time [ Time Frame: At Days 7 and 14 ]
    Expressed as 1/reaction time in milliseconds

  7. Psychomotor Vigilance Test (PVT) number of errors of commission [ Time Frame: At Days 7 and 14 ]
    Number of responses without a stimulus or response time < 100 milliseconds

  8. Toronto Hospital Alert Test (THAT) [ Time Frame: At Days 7 and 14 ]
    10-item self-report questionnaire designed to measure perceived alertness



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, age 21 to 65 years inclusive
  2. Diagnosis of narcolepsy per ICSD-3 or DSM-5
  3. BMI 18 to <40 kg/m2
  4. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Female subjects who are pregnant, nursing, or lactating
  2. Moderate or severe sleep apnea
  3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
  4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  5. History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
  6. History of bariatric surgery within the past year or a history of any gastric bypass procedure
  7. Presence or history of significant cardiovascular disease
  8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806908


Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6229
Contact: Annamiek Vermeeren, MD    +31 (0)43 3881952    a.vermeeren@maastrichtuniversity.nl   
Principal Investigator: Jan Ramaekers, PhD         
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Study Director: Dan Chen, MD, PhD Jazz Pharmaceuticals
Study Director: Tatiana Kharkevitch, MD Jazz Pharmaceuticals
Principal Investigator: Jan Ramaekers, PhD Maastricht University

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02806908     History of Changes
Other Study ID Numbers: 15-005
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Jazz Pharmaceuticals:
Driving

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders