PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Public ClinicalTrials.gov record NCT00107848. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12 months. Safety and tolerability will be evaluated throughout the study by means of adverse event information, clinical laboratory test results, vital signs measurements, and body weight and height measurements; quarterly physical examination findings; and 12 lead electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief Intelligence Test (KBIT 2).
Study identification
- NCT ID
- NCT00107848
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 280 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- Sep 2005 (Type not available)
- Last update posted
- May 9, 2014
2004 – 2005
United States locations
- U.S. sites
- 55
- U.S. states
- 27
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Robert Doekel, Jr., M.D. | Birmingham | Alabama | 35213 | — |
| Chris M. Makris, M.D. | Birmingham | Alabama | 35233 | — |
| Barbara Harris, Ph.D. | Phoenix | Arizona | 85050 | — |
| Derek Loewy, Ph.D. | Tucson | Arizona | 85712 | — |
| Joseph McCarty, M.D. | Fort Smith | Arkansas | 72913 | — |
| Samuel Boellner, M.D. | Little Rock | Arkansas | 72205 | — |
| Julie Thompson-Dobkin, D.O. | Huntington Beach | California | 92648 | — |
| Mark Buchfuhrer, M.D. | Long Beach | California | 90806 | — |
| Yury Furman, M.D. | Los Angeles | California | 90048 | — |
| Stuart Menn, M.D. | Palm Springs | California | 92262 | — |
| Lawrence Sher, M.D. | Rolling Hills Estates | California | 90274 | — |
| Milton K. Erman, M.D. | San Diego | California | 92121 | — |
| Jed Black, M.D. | Stanford | California | 94305 | — |
| Edward O'Malley | Norwalk | Connecticut | 06856 | — |
| Elias H. Sarkis | Gainesville | Florida | 32607 | — |
| Americo Padilla, M.D. | Miami | Florida | 33173 | — |
| Martin A. Cohn, M.D. | Naples | Florida | 34110 | — |
| D. Alan Lankford, Ph.D. | Atlanta | Georgia | 30342 | — |
| Gary Montgomery, M.D. | Atlanta | Georgia | 30342 | — |
| Jerry Silverboard, M.D. | Atlanta | Georgia | 30342 | — |
| Charles Wells, Jr., M.D. | Macon | Georgia | 31208 | — |
| Joel Greenberg | Savannah | Georgia | 31405 | — |
| Robert M. Cohen | Stockbridge | Georgia | 30281 | — |
| Stephen H. Sheldon, D.O., FAAP | Chicago | Illinois | 60614 | — |
| Michael Kohrman, M.D. | Chicago | Illinois | 60637 | — |
| James Cook, M.D. | Danville | Indiana | 46122 | — |
| William Leeds, D.O. | Topeka | Kansas | 66606 | — |
| Karen Waters, M.D. | Louisville | Kentucky | 40202 | — |
| Margaret Ann Springer, M.D. | Shreveport | Louisiana | 71103 | — |
| Helene A. Emsellem, M.D. | Chevy Chase | Maryland | 20815 | — |
| Marc Raphaelson | Frederick | Maryland | 21702 | — |
| George Zureikat, M.D. | Flint | Michigan | 48503 | — |
| John Harsh, Ph.D., DABSM | Hattiesburg | Mississippi | 39401 | — |
| William Torch, M.D., MS | Reno | Nevada | 89502 | — |
| Kathleen Ryan, M.D. | Mount Laurel | New Jersey | 08054 | — |
| Monroe Karetzky, M.D. | Newark | New Jersey | 07112 | — |
| Lee Brooks, M.D. | Princeton | New Jersey | 08540 | — |
| Marc Seelagy, M.D. | Trenton | New Jersey | 08629 | — |
| Gary Zammit, M.D. | New York | New York | 10025 | — |
| Carol Rosen | Cleveland | Ohio | 44106 | — |
| Michael Neeb, Ph.D. | Toledo | Ohio | 43608 | — |
| Ramalinga Reddy | Toledo | Ohio | 43608 | — |
| William C. Orr, Ph.D. | Oklahoma City | Oklahoma | 73112 | — |
| Jorg Pahl, M.D. | Oklahoma City | Oklahoma | 73118 | — |
| Judith Owens, M.D., MPH | Providence | Rhode Island | 02903 | — |
| Richard Bogan, M.D., FCCP | Columbia | South Carolina | 29201 | — |
| Julie Jacques, D.O. | Morristown | Tennessee | 37814 | — |
| John Hudson, M.D. | Austin | Texas | 78756 | — |
| David Sperry, M.D. | Dallas | Texas | 75230 | — |
| Todd J. Swick, M.D. | Houston | Texas | 77024 | — |
| Jerry J. Tomasovic, M.D. | San Antonio | Texas | 78258 | — |
| Radiant Research, Salt Lake City | Salt Lake City | Utah | 84107-7591 | — |
| James M. Ferguson, M.D. | Salt Lake City | Utah | 84107 | — |
| James Perlstrom | Fairfax | Virginia | 22030 | — |
| Robert J. Reichler | Seattle | Washington | 98133 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00107848, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00107848 live on ClinicalTrials.gov.