Status:
COMPLETED
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Lead Sponsor:
Cephalon
Conditions:
Excessive Daytime Sleepiness
Narcolepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstruc...
Eligibility Criteria
Inclusion
- Patients are included in the study if all of the following criteria are met:
- Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible.
- The patient has completed a cephalon-sponsored double-blind study (study C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and the investigator has recommended they be enrolled.
- Patients with OSAHS must continue to be regular users of nCPAP therapy, which the investigator considers to remain effective. Patients with chronic SWSD must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration.
- The patient is considered to be in good health.
- 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 \[IUD\]).
- 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
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Have any clinically significant, uncontrolled medical conditions (treated or untreated).
- Have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD.
- Consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine.
- Use any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before visit 1.
- 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) (American Psychiatric Association 1994).
- Have a positive urine drug screen (UDS) (subjects enrolling in this open-label study within 7 days after completing the double-blind study may be enrolled without UDS results).
- Have a clinically significant deviation from normal in the physical examination.
- Are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study.
- Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Have a known clinically significant drug sensitivity to stimulants.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
743 Patients enrolled
Trial Details
Trial ID
NCT00228553
Start Date
May 1 2004
End Date
July 1 2006
Last Update
July 19 2013
Active Locations (100)
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1
Sleep Disorders Ctr of Alabama
Birmingham, Alabama, United States, 35213
2
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
3
Psypharma Clinical Research
Phoenix, Arizona, United States, 85050
4
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913