Status:
COMPLETED
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Lead Sponsor:
Cephalon
Conditions:
Narcolepsy
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients...
Eligibility Criteria
Inclusion
- Patients are included in the study if all of the following criteria are met:
- Written informed consent is obtained.
- Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
- The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
- Narcolepsy-Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.
- OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
- Previous 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 effective, in the opinion of the investigator.
- Evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of the nights).
- Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study.
- 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.)
- 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 \[IUD\]).
- 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.
- 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 or more than 8 cups of coffee 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 baseline visit
- 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)
- have a positive UDS at the screening visit
- 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 used an investigational drug within 1 month before the screening visit
- 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 :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00078312
Start Date
January 1 2004
End Date
July 1 2006
Last Update
July 19 2013
Active Locations (50)
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1
Pivotal Research Centers
Peoria, Arizona, United States, 85381
2
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States, 85014
3
Radiant Research - Tucson
Tucson, Arizona, United States, 85710
4
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913