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

A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)

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).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Shift-Work Sleep Disorder
• Intervention / Treatment: Drug: CEP-10953 (Armodafinil)

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105 077
    • Institute of Pulmonology
  • Moscow, Russian Federation, 107 014
    • Moscow City Somnological Center
  • Moscow, Russian Federation, 115 682
    • City Clinical Hospital No. 83
  • Moscow, Russian Federation, 119 285
    • United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation
  • Moscow, Russian Federation, 127 644
    • City Clinical Hospital No. 81
  • Moscow, Russian Federation, 143 088
    • Center of Rehabilitation of Presidential Medical Center
  • Saint Petersburg, Russian Federation, 196 128
    • Cardioclinic
  • Saint Petersburg, Russian Federation, 197 022
    • Clinic of Neurology and Neurosurgery of Saint Petersburg
  • Saint-Petersburg, Russian Federation, 194 291
    • Medical Sanitary Unit No. 122 of Saint-Petersburg
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
    • Phoenix, Arizona, United States, 85014
      • Central Phoenix Medical Clinic, LLC
    • Tucson, Arizona, United States, 85710
      • Radiant Research - Tucson
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Central Arkansas Research
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Center for Sleep Medicine
  • California
    • Lafayette, California, United States, 94549
      • Bay Area Research Institute
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Pasadena, California, United States, 91105
      • Neuro-Therapeutics Inc.
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Diego, California, United States, 92105
      • Synergy Clinical Research Center
    • San Diego, California, United States, 92123
      • BMR HealthQuest Clinical Trials
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Rocky Mountain Center for Clinical Research
  • Florida
    • Ft. Lauderdale, Florida, United States, 33308
      • Therafirst Medical Centers
    • Hallandale, Florida, United States, 33009
      • Precision Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • St. Petersburg, Florida, United States, 33707
      • Clinical Research Group of St. Petersburg
  • Idaho
    • Boise, Idaho, United States, 83704
      • Radiant Research, Boise
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Radiant Research, Chicago
    • Chicago, Illinois, United States, 60610
      • Herron Medical Center, Ltd.
    • Elk Grove Village, Illinois, United States, 60007
      • Radiant Research Alexian Brothers
    • Northfield, Illinois, United States, 60093
      • Henry W. Lahmeyer, MD and Associates
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Vince and Associates Clinical Research
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • NeuroTrials Research of New Orleans, LLC
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Marc Raphaelson, MD, PA
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head-Pain Neurological Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • CNS Research Institute, PC
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates, LLP
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • North Coast Clinical Trials, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73109
      • Clinical Research Studies
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • Lehigh Valley Hospital Hospital
    • Pottstown, Pennsylvania, United States, 19464
      • Center for Sleep Disorders, Inc.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SleepMed of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78229
      • Radiant Research, San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Radiant Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cephalon

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: February 23, 2004
• First Submitted That Met QC Criteria: February 24, 2004
• First Posted (Estimate): February 25, 2004

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; nCPAP; Narcolepsy; Cataplexy; Excessive Sleepiness; Sleep Attacks; Nuvigil; Cephalon, Inc; Circadian Rhythm Disorder; Obstructive Sleep Hypopnea; Chronic Shift Work Sleep Disorder; Chronic SWSD; Shift Worker; Cepahlon
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Signs and Symptoms, Respiratory; Chronobiology Disorders; Disorders of Excessive Somnolence; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Disease; Sleep Wake Disorders; Apnea; Parasomnias; Sleep Disorders, Circadian Rhythm; Narcolepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C10953/3023/ES/MN