Status:
COMPLETED
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
Lead Sponsor:
Cephalon
Conditions:
Obstructive Sleep Apnea
Hypopnea
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstr...
Eligibility Criteria
Inclusion
- Patients are included in the study if all of the following criteria are met:
- Written informed consent is obtained.
- The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
- The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
- The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
- The patient meets the following nCPAP therapy requirements:
- Adequate education and intervention efforts to encourage nCPAP therapy use must be documented.
- A patient's nCPAP therapy regimen must be stable for at least 4 weeks.
- nCPAP therapy is shown to be effective, with effectiveness defined as having an apnea-hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy.
- Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2-week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights).
- The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
- 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.
- The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more.
- The patient has an ESS score of 10 or more.
- The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
- The patient is able to complete self rating scales and computer-based testing.
- The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Exclusion
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
- has a probable diagnosis of a current sleep disorder other than OSAHS
- consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day
- 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
- 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)
- has a positive urine drug screen (UDS)
- has a clinically significant deviation from normal in the physical examination
- is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- has used an investigational drug within 1 month before the initial screening visit
- has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
- has a known clinically significant drug sensitivity to stimulants or modafinil
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00078325
Start Date
February 1 2004
End Date
November 1 2004
Last Update
July 19 2013
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