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CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
This study is currently recruiting patients.
| Sponsored by: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder |
Drug: CEP-10953 |
Phase III |
MedlinePlus related topics: Neurologic Diseases; Occupational Health; Sleep Apnea; Sleep Disorders
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
Expected Total Enrollment: 300
Study start: November 2003;
Study completion: June 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
(a) Written informed consent is obtained.
(b) Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
(c) The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
(d) The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.)
(e) The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
(f) The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments.
(g) The patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
(a) have any clinically significant, uncontrolled medical conditions (treated or untreated)
(b) have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD
(c) consume caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine or more than 8 cups of coffee per day
(d) used any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before the baseline visit
(e) have a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV)
(f) have a positive UDS at the screening visit
(g) have a clinically significant deviation from normal in the physical examination
(h) are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study
(i) have used an investigational drug within 1 month before the screening visit
(j) have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
(k) have a known clinically significant drug sensitivity to stimulants
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