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Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

2014-08-27 03:55:01 | BioPortfolio

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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Narcolepsy

Intervention

Xyrem + Modafinil Placebo, Xyrem Placebo + Modafinil Placebo, Xyrem Placebo + Modafinil at established dose, Xyrem + Modafinil at established dose

Location

Pulmonary Associates, PA
Phoenix
Arizona
United States
85006

Status

Completed

Source

Orphan Medical

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:01-0400

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