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

NCT00078312 | Completed Phase 3 Results

• 1 other identifier: C10953/3023/ES/MN
• Study Type: interventional
• Target: 328
• Locations: 2 countries
• Sites: 50

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

Keywords

Excessive Sleepiness; Narcolepsy; Cataplexy; Sleep Attacks; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Chronic Shift Work Sleep Disorder; Chronic SWSD; Circadian Rhythm Disorder; Shift Worker; Cepahlon; Cephalon, Inc; Nuvigil

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability as Measured by Number of Participants With Adverse Events

  Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.

  Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter

Interventions

CEP-10953 (Armodafinil) DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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

Sponsors & Collaborators

• Cephalon: lead

Study Sites (50)

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, 85014, United States

Location

Radiant Research - Tucson

Tucson, Arizona, 85710, United States

Location

Central Arkansas Research

Hot Springs, Arkansas, 71913, United States

Location

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72205, United States

Location

Bay Area Research Institute

Lafayette, California, 94549, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Neuro-Therapeutics Inc.

Pasadena, California, 91105, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Synergy Clinical Research Center

San Diego, California, 92105, United States

Location

BMR HealthQuest Clinical Trials

San Diego, California, 92123, United States

Location

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

Therafirst Medical Centers

Fort Lauderdale, Florida, 33308, United States

Location

Precision Research

Hallandale, Florida, 33009, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

Radiant Research, Boise

Boise, Idaho, 83704, United States

Location

Herron Medical Center, Ltd.

Chicago, Illinois, 60610, United States

Location

Radiant Research, Chicago

Chicago, Illinois, 60610, United States

Location

Radiant Research Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

Location

Henry W. Lahmeyer, MD and Associates

Northfield, Illinois, 60093, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66211, United States

Location

NeuroTrials Research of New Orleans, LLC

Metairie, Louisiana, 70001, United States

Location

Marc Raphaelson, MD, PA

Frederick, Maryland, 21702, United States

Location

Michigan Head-Pain Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Somnos Laboratories, Inc

Lincoln, Nebraska, 68510, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

CNS Research Institute, PC

Clementon, New Jersey, 08021, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

North Coast Clinical Trials, Inc

Beachwood, Ohio, 44122, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Clinical Research Studies

Oklahoma City, Oklahoma, 73109, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital Hospital

Allentown, Pennsylvania, 18105, United States

Location

Center for Sleep Disorders, Inc.

Pottstown, Pennsylvania, 19464, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Radiant Research, San Antonio

San Antonio, Texas, 78229, United States

Location

Radiant Research

Salt Lake City, Utah, 84107, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Institute of Pulmonology

Moscow, 105 077, Russia

Location

Moscow City Somnological Center

Moscow, 107 014, Russia

Location

City Clinical Hospital No. 83

Moscow, 115 682, Russia

Location

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

Moscow, 119 285, Russia

Location

City Clinical Hospital No. 81

Moscow, 127 644, Russia

Location

Center of Rehabilitation of Presidential Medical Center

Moscow, 143 088, Russia

Location

Medical Sanitary Unit No. 122 of Saint-Petersburg

Saint Petersburg, 194 291, Russia

Location

Cardioclinic

Saint Petersburg, 196 128, Russia

Location

Clinic of Neurology and Neurosurgery of Saint Petersburg

Saint Petersburg, 197 022, Russia

Location

MeSH Terms

Conditions

Narcolepsy; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorders, Circadian Rhythm; Disorders of Excessive Somnolence; Cataplexy; Chronobiology Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Occupational Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Sponsor's Medical Director, Clinical Research
• Organization: Cephalon

1-877-237-4879

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2004
• First Posted: February 25, 2004
• Study Start: January 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 19, 2013
• Results First Posted: February 22, 2010

Record last verified: 2013-07

Locations

RU (9); US (41)