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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00214968 |
Purpose
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 obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Excessive Daytime Sleepiness Narcolepsy |
Drug: PROVIGIL (modafinil) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 6-Month Open Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome |
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusions Criteria:
Exclusion Criteria: Patients are excluded for participating in this if 1 or more of the following criteria are met:
Contacts and Locations| Australia | |
| Princess Margaret Children's H | |
| Perth, Australia, WA 6100 | |
| Czech Republic | |
| Charles University | |
| Prague, Czech Republic, 12800 | |
| Finland | |
| Rinnekoti Research Center | |
| Espoo, Finland, FI 02980 | |
| University of Kuopio | |
| Kuopio, Finland | |
| University of Oulu | |
| Oulu, Finland | |
| Sleep Research Unit Dentalia | |
| Turku, Finland | |
| France | |
| Hopital Debrousse | |
| Lyon, Cedex 05, France, 69322 | |
| Hopital Guy de Chauliac | |
| Montpellier, Cedex 05, France, 34295 | |
| CHU Hopital Roger Salengro | |
| Lille, Cedex, France, 59037 | |
| CHU Grenoble | |
| Grenoble, France, 38043 | |
| Hopital Robert Debre | |
| Paris, France, 75019 | |
| Israel | |
| Pediatric Sleep Clinic | |
| Beer Sheva, Israel | |
| Meyer Children's Hospital | |
| Haifa, Israel, 31096 | |
| Dana Children's Hospital | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Centro per lo Studio | |
| Bologna, Italy, 40123 | |
| Centro di Chirurgia | |
| Milan, Italy, 20126 | |
| Centro per ldisturbi del sonno | |
| Milano, Italy, 20017 | |
| Clinica Pediatrica | |
| Roma, Italy, 0189 | |
| Centro Del Sonno | |
| Roma, Italy, 0185 | |
| Centro per lo Studio del Sonno | |
| Troina, Italy, 94018 | |
| Mexico | |
| Instituto Nacional | |
| Mexico City, Mexico, D.F. 06720 | |
| Instituto Nacional | |
| Mexico City, Mexico, D.F. 14000 | |
| Hospital General de Mexico | |
| Mexico City, Mexico, D.F. 06720 | |
| Centro Medical de Especialidad | |
| Monterrey, Mexico, 64060 | |
| Hosp. Reg. del ISSSTE-Puebla | |
| Puebla, Mexico | |
| Spain | |
| Instituto Universitario Dexeus | |
| Barcelona, Spain, 08017 | |
| Servicio de Neurofisiologia | |
| Granada, Spain, 18014 | |
| Hosp Gen Univ Gregorio Maranon | |
| Madrid, Spain, 28007 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain, 07014 | |
| Clinica Quiron | |
| Valencia, Spain, 46609 | |
| United Kingdom | |
| Park Hospital for Children | |
| Headington, Oxford, United Kingdom, OX37LQ | |
More Information
| ClinicalTrials.gov Identifier: | NCT00214968 History of Changes |
| Other Study ID Numbers: | C1538/3034/ES/MN |
| Study First Received: | September 14, 2005 |
| Last Updated: | April 20, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Narcolepsy Sleep Apnea, Obstructive Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Sleep Apnea Syndromes Apnea |
Respiration Disorders Respiratory Tract Diseases Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |