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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00078312 |
The primary objective of this study is to evaluate the safety and tolerability of CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD). Safety and tolerability will be evaluated throughout the study through adverse event data, clinical laboratory test evaluations, vital sign measurements, electrocardiography, and physical examination findings.
Condition | Intervention | Phase |
---|---|---|
Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder |
Drug: CEP-10953 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Month, Open Label, Flexible-Dosage Study of the Safety/Efficacy of CEP 10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Study ID Numbers: | C10953/3023/ES/MN |
Study First Received: | February 23, 2004 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00078312 |
Health Authority: | United States: Food and Drug Administration |
Narcolepsy Excessive Sleepiness Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP |
Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil |
Sleep Apnea Syndromes Sleep Disorders, Circadian Rhythm Apnea Sleep Apnea, Obstructive Respiration Disorders Disorders of Environmental Origin Dyssomnias Sleep Disorders Chronobiology Disorders Disorders of Excessive Somnolence Sleep Disorders, Intrinsic |
Signs and Symptoms Cataplexy Respiratory Tract Diseases Mental Disorders Narcolepsy Neurologic Manifestations Signs and Symptoms, Respiratory Occupational Diseases Gelineau's syndrome Arrhythmias, Cardiac |
Pathologic Processes Disease Syndrome Nervous System Diseases |