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NCT00107796 · ClinicalTrials.gov registry record · Phase 3
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
A Phase 3 study of Narcolepsy, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT00107796 is a Phase 3 study of Narcolepsy that has completed, run by Cephalon. The registered enrollment target is 140 participants, below the 369-participant average among 12 other Narcolepsy trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT00107796, a Phase 3 study of Narcolepsy, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Modafinil
Study Locations (20)
California
- Julie Thompson-Dobkin, D.O. - Huntington Beach
- Mark Buchfuhrer, M.D. - Long Beach
- Yury Furman, M.D. - Los Angeles
- Stuart Menn, M.D. - Palm Springs
- Richard Shubin, M.D. - Pasadena
- Lawrence Sher, M.D. - Rolling Hills Estates
- Milton K. Erman, M.D. - San Diego
- Stephen Brooks, M.D. - San Francisco
- Paul Haberman, M.D. - Santa Monica
- Jed Black, M.D. - Stanford
Arizona
- Barbara Harris, Ph.D. - Phoenix
- Derek Loewy, Ph.D. - Tucson
- Stuart Quan, M.D. - Tucson
Arkansas
- Joseph McCarty, M.D. - Fort Smith
- John L. Carroll, M.D. - Little Rock
- Samuel Boellner, M.D. - Little Rock
Alabama
- Robert Doekel, Jr., M.D. - Birmingham
- Chris M. Makris, M.D. - Birmingham
Florida
- Amerigo Padilla, M.D. - Miami
- Martin A. Cohn, M.D. - Naples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00107796
The ClinicalTrials.gov registry entry for NCT00107796 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 369-participant average among 12 other Narcolepsy trials with a reported enrollment target (62% lower). The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Narcolepsy appearing as the primary indexed condition, and to 1 intervention - of which Modafinil is the first listed.
NCT00107796 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00107796 about?
NCT00107796 is a clinical study titled "Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy". 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 Latenc...
What is the current status of trial NCT00107796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2004-10. Estimated completion is 2005-09.
What conditions does trial NCT00107796 study?
This clinical trial studies the following conditions: Narcolepsy.
What interventions are being tested in trial NCT00107796?
The interventions under investigation include: Modafinil (DRUG).
Who is sponsoring clinical trial NCT00107796?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00107796 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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