|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00107809 |
Purpose
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 obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by:
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Drug: Modafinil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome |
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | September 2005 |
PROVIGIL is a trademark of Genelco, SA, licensed to Cephalon, Inc.
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Meet the minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for OSAHS as assessed by all of the following: *clinical history;
*have a previous diagnosis of OSAHS on the basis of NPSG (nocturnal polysomnogram) and/or MSLT at any time before the screening visit. If the patient is a current user of CPAP (continuous positive airway pressure) therapy and is appropriately titrated on CPAP, the AHI ≥5 inclusion criterion is not applicable; *NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, narcolepsy and periodic limb movement with sleep [PLMs]).
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Robert Doekel, Jr., M.D. | |
| Birmingham, Alabama, United States, 35213 | |
| United States, Arizona | |
| Derek Loewy, Ph.D. | |
| Tucson, Arizona, United States, 85712 | |
| Stuart Quan, M.D. | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| John L. Carroll, M.D. | |
| Little Rock, Arkansas, United States, 72202 | |
| Joseph McCarty, M.D. | |
| Fort Smith, Arkansas, United States, 72913 | |
| United States, California | |
| Jed Black, M.D. | |
| Stanford, California, United States, 94305 | |
| Julie Thompson-Dobkin, D.O. | |
| Huntington Beach, California, United States, 92648 | |
| Lawrence Sher, M.D. | |
| Rolling Hills Estates, California, United States, 90274 | |
| Mark Buchfuhrer, M.D. | |
| Long Beach, California, United States, 90806 | |
| Milton K. Erman, M.D. | |
| San Diego, California, United States, 92121 | |
| Paul Haberman, M.D. | |
| Santa Monica, California, United States, 90404 | |
| Richard Shubin, M.D. | |
| Pasadena, California, United States, 91105 | |
| Stephen Brooks, M.D. | |
| San Francisco, California, United States, 94109 | |
| Stuart Menn, M.D. | |
| Palm Springs, California, United States, 92262 | |
| Yury Furman, M.D. | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Amerigo Padilla, M.D. | |
| Miami, Florida, United States, 33173 | |
| Martin A. Cohn, M.D. | |
| Naples, Florida, United States, 34110 | |
| United States, Georgia | |
| D. Alan Lankford, Ph.D. | |
| Atlanta, Georgia, United States, 30342 | |
| Gary Montgomery, M.D. | |
| Atlanta, Georgia, United States, 30342 | |
| Jerry Silverboard, M.D. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Stephen H. Sheldon, D.O., FAAP | |
| Chicago, Illinois, United States, 60614 | |
| Henry Lahmeyer, M.D. | |
| Northfield, Illinois, United States, 60093 | |
| Michael Kohrman, M.D. | |
| Chicago, Illinois, United States, 60637 | |
| Anna Ivanenko, M.D., Ph.D. | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| James Cook, M.D. | |
| Danville, Indiana, United States, 46122 | |
| United States, Kansas | |
| William Leeds, D.O. | |
| Topeka, Kansas, United States, 66606 | |
| United States, Kentucky | |
| Karen Waters, M.D. | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Margaret Ann Springer, M.D. | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Helene A. Emsellem, M.D. | |
| Chevy Chase, Maryland, United States, 20815 | |
| Marc Raphaelson, M.D. | |
| Frederick, Maryland, United States, 21702 | |
| United States, Michigan | |
| Daniela Minecan, M.D. | |
| Ann Arbor, Michigan, United States, 48109 | |
| George Zureikat, M.D. | |
| Flint, Michigan, United States, 48503 | |
| United States, Missouri | |
| Pradeep Sahota, M.D. | |
| Columbia, Missouri, United States, 65212 | |
| United States, Nevada | |
| William Torch, M.D., MS | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| Kathleen Ryan, M.D. | |
| Mount Laurel, New Jersey, United States, 08054 | |
| Lee Brooks, M.D. | |
| Princeton, New Jersey, United States, 08540 | |
| Marc Seelagy, M.D. | |
| Trenton, New Jersey, United States, 08629 | |
| Monroe Karetzky, M.D. | |
| Newark, New Jersey, United States, 07112 | |
| Sushmita Mikkilineni, M.D. | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Gary Zammit, M.D. | |
| New York, New York, United States, 10025 | |
| United States, North Carolina | |
| James Lee, M.D. | |
| Charlotte, North Carolina, United States, 28226 | |
| United States, Ohio | |
| Markus H. Schmidt, M.D., Ph.D. | |
| Dublin, Ohio, United States, 43017 | |
| Martin Scharf, Ph.D. | |
| Cincinnati, Ohio, United States, 45246 | |
| Michael Neeb, Ph.D. | |
| Toledo, Ohio, United States, 43608 | |
| Raouf Amin, MD | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oklahoma | |
| Jorg Pahl, M.D. | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| William C. Orr, Ph.D. | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Dainis Irbe, M.D. | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Guillermo Borrero, M.D. | |
| Clairton, Pennsylvania, United States, 15025 | |
| Jeffery Gould, M.D. | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| William Pistone, M.D. | |
| Allentown, Pennsylvania, United States, 18104 | |
| United States, Rhode Island | |
| Judith Owens, M.D., MPH | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Richard Bogan, M.D., FCCP | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Tennessee | |
| Julie Jacques, D.O. | |
| Morristown, Tennessee, United States, 37814 | |
| United States, Texas | |
| David Sperry, M.D. | |
| Dallas, Texas, United States, 75230 | |
| Jerry J. Tomasovic, M.D. | |
| San Antonio, Texas, United States, 78258 | |
| John Hudson, M.D. | |
| Austin, Texas, United States, 78756 | |
| Todd J. Swick, M.D. | |
| Houston, Texas, United States, 77024 | |
| United States, Utah | |
| James M. Ferguson, M.D. | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Washington | |
| Ralph A. Pascualy, M.D. | |
| Seattle, Washington, United States, 98122 | |
| Canada, Alberta | |
| Adam Moscovitch, M.D. | |
| Calgary, Alberta, Canada, T2X2A8 | |
| Canada, Ontario | |
| Allen Denys, M.D. | |
| Windsor, Ontario, Canada, N9A1C9 | |
| Leonid Kayumov, M.D. | |
| Scarborough, Ontario, Canada, M1S1T7 | |
| Mortimer Mamelak, M.D. | |
| Toronto, Ontario, Canada, M2J2K9 | |
More Information
| Study ID Numbers: | C1538/3028/AP/MN-OSAHS |
| Study First Received: | April 8, 2005 |
| Last Updated: | October 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00107809 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Health Canada: |
|
Pediatric Obstructive sleep Apnea Excessive sleepiness CPAP Pediatric OSAHS |
|
Sleep Apnea Syndromes Apnea Physiological Effects of Drugs Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias Sleep Disorders Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Pharmacologic Actions Modafinil Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Therapeutic Uses Signs and Symptoms, Respiratory Central Nervous System Agents |