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CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
This study is currently recruiting patients.
| Sponsored by: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
Purpose
The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline visit).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Sleep Apnea, Obstructive Sleep Apnea Syndromes |
Drug: CEP-10953 |
Phase III |
MedlinePlus related topics: Sleep Apnea
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 12 Week, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy/Safety of CEP 10953 as Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome
Expected Total Enrollment: 324
Study start: November 2003;
Expected completion: September 2004
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) The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
(c) The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
(d) The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
(e) The patient meets the following nCPAP therapy requirements:
(f) The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
(g) Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using 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]) and agree to continued use of this method for the duration of the study.
(h) The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more.
(i) The patient has an ESS score of 10 or more.
(j) The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
(k) The patient is able to complete self rating scales and computer-based testing.
(l) The patient is 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) has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
(b) has a probable diagnosis of a current sleep disorder other than OSAHS
(c) consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine 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 second screening visit
(e) has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV)
(f) has a positive urine drug screen (UDS)
(g) has a clinically significant deviation from normal in the physical examination
(h) is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
(i) has used an investigational drug within 1 month before the initial screening visit
(j) has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
(k) has a known clinically significant drug sensitivity to stimulants or modafinil
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