Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 231
- Locations
- 39
- Primary Endpoint
- Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
Study Overview
Brief Summary
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1.
Xyrem + Modafinil Placebo
Intervention: Xyrem (Drug)
Group 1.
Xyrem + Modafinil Placebo
Intervention: Modafinil (Placebo) (Drug)
Group 2:
Xyrem Placebo + Modafinil Placebo
Intervention: Xyrem Placebo (Drug)
Group 2:
Xyrem Placebo + Modafinil Placebo
Intervention: Modafinil (Placebo) (Drug)
Group 3
Xyrem Placebo + Modafinil at established dose
Intervention: Xyrem Placebo (Drug)
Group 3
Xyrem Placebo + Modafinil at established dose
Intervention: Modafinil at established dose (Drug)
Group 4:
Xyrem + Modafinil at established dose
Intervention: Xyrem (Drug)
Group 4:
Xyrem + Modafinil at established dose
Intervention: Modafinil at established dose (Drug)
Outcomes
Primary Outcomes
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
Time Frame: Baseline to Week 8
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
Secondary Outcomes
No secondary outcomes reported