Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

NCT ID: NCT00078312

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-07-31

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 with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).

Conditions

Narcolepsy; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Shift-Work Sleep Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CEP-10953 (Armodafinil)

Armodafinil (po) 100 to 250 mg/day up to 12 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients are included in the study if all of the following criteria are met:

1. Written informed consent is obtained.

2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.

3. 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.

4. 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.)

5. 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]).

6. 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.

7. 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 Criteria

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

1. have any clinically significant, uncontrolled medical conditions (treated or untreated)

2. have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD

3. 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

4. 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

5. 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)

6. have a positive UDS at the screening visit

7. have a clinically significant deviation from normal in the physical examination

8. are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study

9. have used an investigational drug within 1 month before the screening visit

10. have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)

11. have a known clinically significant drug sensitivity to stimulants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Locations

Pivotal Research Centers

Peoria, Arizona, United States

Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, United States

Radiant Research - Tucson

Tucson, Arizona, United States

Central Arkansas Research

Hot Springs, Arkansas, United States

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, United States

Bay Area Research Institute

Lafayette, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Neuro-Therapeutics Inc.

Pasadena, California, United States

Anderson Clinical Research

Redlands, California, United States

Synergy Clinical Research Center

San Diego, California, United States

BMR HealthQuest Clinical Trials

San Diego, California, United States

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, United States

Therafirst Medical Centers

Fort Lauderdale, Florida, United States

Precision Research

Hallandale, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, United States

Radiant Research, Boise

Boise, Idaho, United States

Herron Medical Center, Ltd.

Chicago, Illinois, United States

Radiant Research, Chicago

Chicago, Illinois, United States

Radiant Research Alexian Brothers

Elk Grove Village, Illinois, United States

Henry W. Lahmeyer, MD and Associates

Northfield, Illinois, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

NeuroTrials Research of New Orleans, LLC

Metairie, Louisiana, United States

Marc Raphaelson, MD, PA

Frederick, Maryland, United States

Michigan Head-Pain Neurological Institute

Ann Arbor, Michigan, United States

Somnos Laboratories, Inc

Lincoln, Nebraska, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

CNS Research Institute, PC

Clementon, New Jersey, United States

Long Island Clinical Research Associates, LLP

Great Neck, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

North Coast Clinical Trials, Inc

Beachwood, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Clinical Research Studies

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital Hospital

Allentown, Pennsylvania, United States

Center for Sleep Disorders, Inc.

Pottstown, Pennsylvania, United States

SleepMed of South Carolina

Columbia, South Carolina, United States

Radiant Research, San Antonio

San Antonio, Texas, United States

Radiant Research

Salt Lake City, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Institute of Pulmonology

Moscow, , Russia

Moscow City Somnological Center

Moscow, , Russia

City Clinical Hospital No. 83

Moscow, , Russia

United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation

Moscow, , Russia

City Clinical Hospital No. 81

Moscow, , Russia

Center of Rehabilitation of Presidential Medical Center

Moscow, , Russia

Medical Sanitary Unit No. 122 of Saint-Petersburg

Saint Petersburg, , Russia

Cardioclinic

Saint Petersburg, , Russia

Clinic of Neurology and Neurosurgery of Saint Petersburg

Saint Petersburg, , Russia

Countries

United States; Russia

Other Identifiers

C10953/3023/ES/MN

Identifier Type: -

Identifier Source: org_study_id