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

A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) 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 (With an Open-Ended Extension Period)

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

Study Overview

• Status: Completed
• Conditions: Narcolepsy; Excessive Daytime Sleepiness; Chronic Shift Work Sleep Disorder; Obstructive Sleep Apnea/Hypopnea Syndrome
• Intervention / Treatment: Drug: Armodafinil 100 to 250 mg/day

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia
      • Royal Prince Alfred Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St. George Hospital
    • Wentworthville, New South Wales, Australia
      • Westmead Hospital
  • Victoria
    • Clayton, Victoria, Australia
      • Monash Medical Center
    • East Melbourne, Victoria, Australia
      • Melbourne Sleep Disorders Ctr.
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Canadian Sleep Institute
  • Ontario
    • Kitchener, Ontario, Canada, N2G1G1
      • Sleep Clinic
    • Niagara Falls, Ontario, Canada
      • Niagara Clinical Research
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital
    • Parry Sound, Ontario, Canada, P2A 1T3
      • West Parry Sound Health Center
    • Scarborough, Ontario, Canada
      • Sleep and Neuropsychiatry Cent
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada
      • Baycrest Hospital
• France
  • Clamart, France, 92141
    • Hôpital Antoine Béclère
  • Creteil, France, 94010
    • Hospital Henri-Mondor
  • Cedex
    • Strasbourg, Cedex, France, 67091
      • Universitaires de Strasbourg
  • Cedex 05
    • Montpellier, Cedex 05, France, 34295
      • Hôpital Guy de Chauliac
• Germany
  • Freiburg, Germany, D-79104
    • University of Freiburg
  • Marburg, Germany, 35033
    • Klinikum der Philipps
  • Regensburg, Germany, D-93042
    • University of Regensburg
  • Schwalmstadt, Germany, D-34613
    • Hephata Klinik
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • SomniCare Sleep Institute
• Russian Federation
  • Moscow, Russian Federation
    • City Clinical Hospital 33
  • Moscow, Russian Federation
    • City Clinical Hospital 83
  • Saint Petersburg, Russian Federation
    • Clinical Hospital Russian Scie
  • Samara, Russian Federation
    • Multifunction Center of Neurol
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Ctr of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Pulmonary Associates, PA
    • Phoenix, Arizona, United States, 85050
      • PsyPharma Clinical Research
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Central Arkansas Research
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Ins
    • Beverly Hills, California, United States, 90210
      • Southwestern Research
    • Los Angeles, California, United States, 90048
      • Pacific Sleep Medicine Service
    • Palm Springs, California, United States, 92262
      • Pacific Sleep Medicine Service
    • San Diego, California, United States, 92123
      • BMR HealthQuest
    • San Diego, California, United States, 92121
      • Pacific Sleep Medicine Service
    • San Diego, California, United States, 92103
      • Radiant Research San Diego
    • San Francisco, California, United States, 94117
      • Sleep Clinic of San Francisco
    • Santa Monica, California, United States, 90404
      • St. Johns Medical Plaza Sleep
    • Stanford, California, United States, 94305
      • Stanford University
  • Florida
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • St. Petersburg, Florida, United States, 33707
      • St. Petersburg Sleep Disorder
    • Winter Park, Florida, United States, 32789
      • Sleep-Wake Disorder Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Neurotrials Research
    • Atlanta, Georgia, United States, 30342
      • Sleep Disorders Center of GA
    • Macon, Georgia, United States, 31202
      • SLEEPMED, Inc.
    • Marietta, Georgia, United States, 30060
      • Radiant Research Marietta
  • Illinois
    • Northfield, Illinois, United States, 60093
      • Henry Lahmeyer, MD
    • Peoria, Illinois, United States, 61603
      • Peoria Pulmonary Associates
  • Indiana
    • Danville, Indiana, United States, 46122
      • Center for Sleep Disorders
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Vince and Associates Clinical
    • Topeka, Kansas, United States, 66606
      • Topeka Pulmonary
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves Gilbert Clinic
    • Crestview, Kentucky, United States, 45217
      • Community Research
    • Louisville, Kentucky, United States, 40217
      • Chest Medicine Associates DBA
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Neurotrials Research of New Or
    • Slidell, Louisiana, United States, 70461
      • Northshore Research Associates
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Center for Sleep/Wake Disorder
    • Elkton, Maryland, United States, 21021
      • Regional Pulmonary and Sleep
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Newton, Massachusetts, United States, 02459
      • Neurocare, Inc.
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39404
      • Sleep Disorders Center
  • Missouri
    • St. Louis, Missouri, United States, 63105
      • Washington University School o
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Rsch Center of Nevada
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • CNS Research Institute
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • New York University
    • New York, New York, United States, 10025
      • Clinilabs / Sleep Disorders In
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Greensboro, North Carolina, United States, 27408
      • Vital re:Search
    • Hickory, North Carolina, United States, 28602
      • Neurology Associates of Hickor
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Salisbury, North Carolina, United States, 28144
      • Central Carolina Neurology Sle
    • Winston-Salem, North Carolina, United States
      • All Trials Clinical Research
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • St. Alexius Medical Center
  • Ohio
    • Beechwood, Ohio, United States, 44122
      • North Coast Clinical Trials
    • Cincinnati, Ohio, United States, 45219
      • Community Research Management
    • Cincinnati, Ohio, United States, 45246
      • Tri State Sleep Disorders Cent
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Dayton, Ohio, United States, 45428
      • Dept Veterans Affairs Dayton
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine-Neurosci
    • Middleburg Heights, Ohio, United States, 44130
      • Southwest Cleveland Sleep Cent
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Cent
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Clinical Pharmaceutical Trials
  • Pennsylvania
    • Carlisle, Pennsylvania, United States, 17013
      • Capital Region Sleep Disorders
    • Pittsburgh, Pennsylvania, United States, 15221
      • Consolidated Clinical Trials
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical
    • Columbia, South Carolina, United States, 29201
      • SleepMed of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Sleep Disorders Cen
  • Texas
    • Austin, Texas, United States, 78703
      • FutureSearch Trials
    • Dallas, Texas, United States
      • Sleep Medicine Institute
    • Houston, Texas, United States, 77024
      • Houston Sleep Center
    • Houston, Texas, United States, 77030
      • VA Medical CenterSleep Diagnos
    • The Woodlands, Texas, United States, 77380
      • Sadler Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Radiant Research Salt Lake
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospit
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Sleep Medicine Institute
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Allegiance Research Specialist

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:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Armodafinil 100 to 250 mg/day	Drug: Armodafinil 100 to 250 mg/day; Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)	An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. 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.	End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year

Collaborators and Investigators

• Sponsor: Cephalon
• Investigators: Study Director: Sponsor's Medical Director, MD, Cephalon

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 27, 2005
• First Submitted That Met QC Criteria: September 27, 2005
• First Posted (Estimate): September 29, 2005

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

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Disorders of Excessive Somnolence; Sleepiness; 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: C10953/3024/ES/MN