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

NCT00066170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2011-12-29

Study results available
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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.

Conditions

Interventions

DRUG

Xyrem

Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.

DRUG

Xyrem Placebo

Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.

DRUG

Modafinil at established dose

Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.

DRUG

Modafinil (Placebo)

Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Yanping Zheng, MD · Jazz Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-07-31
Completion
2004-11-30

Countries

  • United States
  • France
  • Germany
  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066170 on ClinicalTrials.gov