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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00228553
Recruitment Status : Completed
First Posted : September 29, 2005
Results First Posted : March 31, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder Drug: Armodafinil 100 to 250 mg/day Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 743 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2004
Actual Study Completion Date : July 2006


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).




Primary Outcome Measures :
  1. Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) [ Time Frame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228553


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

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ClinicalTrials.gov Identifier: NCT00228553     History of Changes
Other Study ID Numbers: C10953/3024/ES/MN
First Posted: September 29, 2005    Key Record Dates
Results First Posted: March 31, 2010
Last Update Posted: July 19, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Modafinil
Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Sleepiness
Narcolepsy
Sleep Disorders, Circadian Rhythm
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Disorders of Excessive Somnolence
Chronobiology Disorders
Occupational Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action