At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with narcolepsy per International Classification of Sleep Disorders criteria
- ✓Currently on stable modafinil dose (200-600 mg/day) for ≥3 months, stable for ≥1 month before entry
- ✓Age ≥18 years
- ✓Able and willing to complete entire trial protocol including transportation arrangements
- ✕Sleep apnea (Apnea Index >10/hour or AHI >15/hour)
- ✕Other primary causes of excessive daytime sleepiness (e.g., severe periodic leg movement syndrome, sleep deprivation)
- ✕Current use of hypnotics, tranquilizers, sedating antihistamines, benzodiazepines, or clonidine
- ✕Any anticonvulsant use—ineligible even with planned washout
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Xyrem, Xyrem Placebo, and 2 other interventions for Narcolepsy. Completed, enrolled 231 participants across 40 sites in 4 countries.
Detailed 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 Details
Timeline
Interventions
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.