Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

Completed · Phase 3

Conditions studied: Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder

In brief

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, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Key facts

Study ID

NCT00228553

Run by

Cephalon

People needed

743

Starts

2004-05-01

Expected to finish

2006-07-01

Last updated by the study team

2013-07-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• Psypharma Clinical Research — Phoenix, Arizona, United States
• Central Arkansas Research — Hot Springs, Arkansas, United States
• Advanced Clinical Research Ins — Anaheim, California, United States
• Southwestern Research — Beverly Hills, California, United States
• Pacific Sleep Medicine Service — Los Angeles, California, United States
• Pacific Sleep Medicine Service — Palm Springs, California, United States
• Radiant Research San Diego — San Diego, California, United States
• Pacific Sleep Medicine Service — San Diego, California, United States
• BMR HealthQuest — San Diego, California, United States
• Sleep Clinic of San Francisco — San Francisco, California, United States
• St. Johns Medical Plaza Sleep — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• PAB Clinical Research — Brandon, Florida, United States
• St. Petersburg Sleep Disorder — St. Petersburg, Florida, United States
• Sleep-Wake Disorder Center — Winter Park, Florida, United States
• Neurotrials Research — Atlanta, Georgia, United States
• Sleep Disorders Center of GA — Atlanta, Georgia, United States
• SLEEPMED, Inc. — Macon, Georgia, United States
• Radiant Research Marietta — Marietta, Georgia, United States
• Henry Lahmeyer, MD — Northfield, Illinois, United States
• Peoria Pulmonary Associates — Peoria, Illinois, United States
• Center for Sleep Disorders — Danville, Indiana, United States
• University of Iowa Hospitals — Iowa City, Iowa, United States
• Sleep Disorders Ctr of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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