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Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
NCT00107796 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00107796 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00107796?
The interventions under investigation include: Modafinil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00107796?
This trial is sponsored by Cephalon, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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