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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR PROVIGIL

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Clinical Trials for Provigil

Trial ID Title Status Sponsor Phase Summary
NCT00066170 Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy Completed Jazz Pharmaceuticals Phase 3 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.
NCT00086281 Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients Completed Jazz Pharmaceuticals Phase 4 To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).
NCT00107796 Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Completed Cephalon Phase 3 Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with narcolepsy, as assessed by: - mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6 or early termination) - the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post-baseline observation (week 6 or early termination).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Provigil

Condition Name

Condition Name for Provigil
Intervention Trials
Narcolepsy 6
Healthy 3
Sleep Apnea, Obstructive 2
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Condition MeSH

Condition MeSH for Provigil
Intervention Trials
Narcolepsy 6
Fatigue 5
Sleep Apnea, Obstructive 4
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Clinical Trial Locations for Provigil

Trials by Country

Trials by Country for Provigil
Location Trials
United States 146
Canada 8
Germany 2
France 2
Israel 1
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Trials by US State

Trials by US State for Provigil
Location Trials
California 9
New York 9
Pennsylvania 8
South Carolina 6
Maryland 5
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Clinical Trial Progress for Provigil

Clinical Trial Phase

Clinical Trial Phase for Provigil
Clinical Trial Phase Trials
Phase 4 9
Phase 3 7
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Provigil
Clinical Trial Phase Trials
Completed 24
Recruiting 3
Terminated 2
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Clinical Trial Sponsors for Provigil

Sponsor Name

Sponsor Name for Provigil
Sponsor Trials
Cephalon 8
National Institute on Drug Abuse (NIDA) 5
National Institute of Mental Health (NIMH) 2
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Sponsor Type

Sponsor Type for Provigil
Sponsor Trials
Other 30
Industry 16
NIH 9
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