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)
1 other identifier
interventional
743
7 countries
100
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedResults Posted
Study results publicly available
March 31, 2010
CompletedJuly 19, 2013
July 1, 2013
September 27, 2005
June 1, 2009
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALArmodafinil 100 to 250 mg/day
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (100)
Sleep Disorders Ctr of Alabama
Birmingham, Alabama, 35213, United States
Pulmonary Associates, PA
Phoenix, Arizona, 85006, United States
Psypharma Clinical Research
Phoenix, Arizona, 85050, United States
Central Arkansas Research
Hot Springs, Arkansas, 71913, United States
Advanced Clinical Research Ins
Anaheim, California, 92801, United States
Southwestern Research
Beverly Hills, California, 90210, United States
Pacific Sleep Medicine Service
Los Angeles, California, 90048, United States
Pacific Sleep Medicine Service
Palm Springs, California, 92262, United States
Radiant Research San Diego
San Diego, California, 92103, United States
Pacific Sleep Medicine Service
San Diego, California, 92121, United States
BMR HealthQuest
San Diego, California, 92123, United States
Sleep Clinic of San Francisco
San Francisco, California, 94117, United States
St. Johns Medical Plaza Sleep
Santa Monica, California, 90404, United States
Stanford University
Stanford, California, 94305, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
St. Petersburg Sleep Disorder
St. Petersburg, Florida, 33707, United States
Sleep-Wake Disorder Center
Winter Park, Florida, 32789, United States
Neurotrials Research
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of GA
Atlanta, Georgia, 30342, United States
SLEEPMED, Inc.
Macon, Georgia, 31202, United States
Radiant Research Marietta
Marietta, Georgia, 30060, United States
Henry Lahmeyer, MD
Northfield, Illinois, 60093, United States
Peoria Pulmonary Associates
Peoria, Illinois, 61603, United States
Center for Sleep Disorders
Danville, Indiana, 46122, United States
University of Iowa Hospitals
Iowa City, Iowa, 52242, United States
Vince and Associates Clinical
Overland Park, Kansas, 66211, United States
Topeka Pulmonary
Topeka, Kansas, 66606, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Community Research
Crestview, Kentucky, 45217, United States
Chest Medicine Associates DBA
Louisville, Kentucky, 40217, United States
Neurotrials Research of New Or
Metairie, Louisiana, 70001, United States
Northshore Research Associates
Slidell, Louisiana, 70461, United States
Center for Sleep/Wake Disorder
Chevy Chase, Maryland, 20815, United States
Regional Pulmonary and Sleep
Elkton, Maryland, 21021, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
Sleep Disorders Center
Hattiesburg, Mississippi, 39404, United States
Washington University School o
St Louis, Missouri, 63105, United States
Clinical Rsch Center of Nevada
Las Vegas, Nevada, 89104, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
New York University
New York, New York, 10016, United States
Clinilabs / Sleep Disorders In
New York, New York, 10025, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Vital re:Search
Greensboro, North Carolina, 27408, United States
Neurology Associates of Hickor
Hickory, North Carolina, 28602, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Central Carolina Neurology Sle
Salisbury, North Carolina, 28144, United States
All Trials Clinical Research
Winston-Salem, North Carolina, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
North Coast Clinical Trials
Beechwood, Ohio, 44122, United States
Community Research Management
Cincinnati, Ohio, 45219, United States
Tri State Sleep Disorders Cent
Cincinnati, Ohio, 45246, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Dept Veterans Affairs Dayton
Dayton, Ohio, 45428, United States
Ohio Sleep Medicine-Neurosci
Dublin, Ohio, 43017, United States
Southwest Cleveland Sleep Cent
Middleburg Heights, Ohio, 44130, United States
St. Vincent Mercy Medical Cent
Toledo, Ohio, 43608, United States
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104, United States
Capital Region Sleep Disorders
Carlisle, Pennsylvania, 17013, United States
Consolidated Clinical Trials
Pittsburgh, Pennsylvania, 15221, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Lowcountry Lung and Critical
Charleston, South Carolina, 29406, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
St. Thomas Sleep Disorders Cen
Nashville, Tennessee, 37205, United States
FutureSearch Trials
Austin, Texas, 78703, United States
Sleep Medicine Institute
Dallas, Texas, United States
Houston Sleep Center
Houston, Texas, 77024, United States
VA Medical CenterSleep Diagnos
Houston, Texas, 77030, United States
Sadler Clinic
The Woodlands, Texas, 77380, United States
Radiant Research Salt Lake
Salt Lake City, Utah, 84107, United States
Sentara Norfolk General Hospit
Norfolk, Virginia, 23507, United States
Swedish Sleep Medicine Institute
Seattle, Washington, 98122, United States
Allegiance Research Specialist
Wauwatosa, Wisconsin, 53226, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Monash Medical Center
Clayton, Victoria, Australia
Melbourne Sleep Disorders Ctr.
East Melbourne, Victoria, Australia
Canadian Sleep Institute
Calgary, Alberta, Canada
Sleep Clinic
Kitchener, Ontario, N2G1G1, Canada
Niagara Clinical Research
Niagara Falls, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
West Parry Sound Health Center
Parry Sound, Ontario, P2A 1T3, Canada
Sleep and Neuropsychiatry Cent
Scarborough Village, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Baycrest Hospital
Toronto, Ontario, Canada
Hopital Guy de Chauliac
Montpellier, Cedex 05, 34295, France
Universitaires de Strasbourg
Strasbourg, Cedex, 67091, France
Hopital Antoine Beclere
Clamart, Clamart, 92141, France
Hospital Henri-Mondor
Créteil, 94010, France
University of Freiburg
Freiburg im Breisgau, D-79104, Germany
Klinikum der Philipps
Marburg, 35033, Germany
University of Regensburg
Regensburg, D-93042, Germany
Hephata Klinik
Schwalmstadt, D-34613, Germany
SomniCare Sleep Institute
San Juan, 00918, Puerto Rico
City Clinical Hospital 33
Moscow, Russia
City Clinical Hospital 83
Moscow, Russia
Clinical Hospital Russian Scie
Saint Petersburg, Russia
Multifunction Center of Neurol
Samara, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sponsor's Medical Director, Clinical Research
- Organization
- Cephalon
Study Officials
- STUDY DIRECTOR
Sponsor's Medical Director, MD
Cephalon
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
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
May 1, 2004
Study Completion
July 1, 2006
Last Updated
July 19, 2013
Results First Posted
March 31, 2010
Record last verified: 2013-07