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

Narcolepsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228553
• Other study ID #: C10953/3024/ES/MN
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: July 12, 2013
• Start date: May 2004
• Est. completion date: July 2006

Study information

• Verified date: July 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Shift Work Sleep Disorder
• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

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).

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Center	Clayton	Victoria
Australia	Melbourne Sleep Disorders Ctr.	East Melbourne	Victoria
Australia	St. George Hospital	Kogarah	New South Wales
Australia	Westmead Hospital	Wentworthville	New South Wales
Canada	Canadian Sleep Institute	Calgary	Alberta
Canada	Sleep Clinic	Kitchener	Ontario
Canada	Niagara Clinical Research	Niagara Falls	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	West Parry Sound Health Center	Parry Sound	Ontario
Canada	Sleep and Neuropsychiatry Cent	Scarborough	Ontario
Canada	Baycrest Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
France	Hopital Antoine Beclere	Clamart
France	Hospital Henri-Mondor	Creteil
France	Hopital Guy de Chauliac	Montpellier	Cedex 05
France	Universitaires de Strasbourg	Strasbourg	Cedex
Germany	University of Freiburg	Freiburg
Germany	Klinikum der Philipps	Marburg
Germany	University of Regensburg	Regensburg
Germany	Hephata Klinik	Schwalmstadt
Puerto Rico	SomniCare Sleep Institute	San Juan
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
United States	Advanced Clinical Research Ins	Anaheim	California
United States	Neurotrials Research	Atlanta	Georgia
United States	Sleep Disorders Center of GA	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	North Coast Clinical Trials	Beechwood	Ohio
United States	McLean Hospital	Belmont	Massachusetts
United States	Southwestern Research	Beverly Hills	California
United States	Sleep Disorders Ctr of Alabama	Birmingham	Alabama
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	PAB Clinical Research	Brandon	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Capital Region Sleep Disorders	Carlisle	Pennsylvania
United States	Lowcountry Lung and Critical	Charleston	South Carolina
United States	Center for Sleep/Wake Disorder	Chevy Chase	Maryland
United States	Community Research Management	Cincinnati	Ohio
United States	Tri State Sleep Disorders Cent	Cincinnati	Ohio
United States	CNS Research Institute	Clementon	New Jersey
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Community Research	Crestview	Kentucky
United States	Sleep Medicine Institute	Dallas	Texas
United States	Center for Sleep Disorders	Danville	Indiana
United States	Dept Veterans Affairs Dayton	Dayton	Ohio
United States	Ohio Sleep Medicine-Neurosci	Dublin	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	Regional Pulmonary and Sleep	Elkton	Maryland
United States	Vital re:Search	Greensboro	North Carolina
United States	Sleep Disorders Center	Hattiesburg	Mississippi
United States	Neurology Associates of Hickor	Hickory	North Carolina
United States	Central Arkansas Research	Hot Springs	Arkansas
United States	Houston Sleep Center	Houston	Texas
United States	VA Medical CenterSleep Diagnos	Houston	Texas
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Clinical Rsch Center of Nevada	Las Vegas	Nevada
United States	Pacific Sleep Medicine Service	Los Angeles	California
United States	Chest Medicine Associates DBA	Louisville	Kentucky
United States	SLEEPMED, Inc.	Macon	Georgia
United States	Radiant Research Marietta	Marietta	Georgia
United States	Neurotrials Research of New Or	Metairie	Louisiana
United States	Southwest Cleveland Sleep Cent	Middleburg Heights	Ohio
United States	St. Thomas Sleep Disorders Cen	Nashville	Tennessee
United States	Clinilabs / Sleep Disorders In	New York	New York
United States	New York University	New York	New York
United States	Neurocare, Inc.	Newton	Massachusetts
United States	Sentara Norfolk General Hospit	Norfolk	Virginia
United States	Henry Lahmeyer, MD	Northfield	Illinois
United States	Vince and Associates Clinical	Overland Park	Kansas
United States	Pacific Sleep Medicine Service	Palm Springs	California
United States	Peoria Pulmonary Associates	Peoria	Illinois
United States	Psypharma Clinical Research	Phoenix	Arizona
United States	Pulmonary Associates, PA	Phoenix	Arizona
United States	Consolidated Clinical Trials	Pittsburgh	Pennsylvania
United States	Wake Research Associates	Raleigh	North Carolina
United States	Central Carolina Neurology Sle	Salisbury	North Carolina
United States	Radiant Research Salt Lake	Salt Lake City	Utah
United States	BMR HealthQuest	San Diego	California
United States	Pacific Sleep Medicine Service	San Diego	California
United States	Radiant Research San Diego	San Diego	California
United States	Sleep Clinic of San Francisco	San Francisco	California
United States	St. Johns Medical Plaza Sleep	Santa Monica	California
United States	Swedish Sleep Medicine Institute	Seattle	Washington
United States	Northshore Research Associates	Slidell	Louisiana
United States	Washington University School o	St. Louis	Missouri
United States	St. Petersburg Sleep Disorder	St. Petersburg	Florida
United States	Stanford University	Stanford	California
United States	Sadler Clinic	The Woodlands	Texas
United States	St. Vincent Mercy Medical Cent	Toledo	Ohio
United States	Topeka Pulmonary	Topeka	Kansas
United States	Clinical Pharmaceutical Trials	Tulsa	Oklahoma
United States	Omega Medical Research	Warwick	Rhode Island
United States	Allegiance Research Specialist	Wauwatosa	Wisconsin
United States	All Trials Clinical Research	Winston-Salem	North Carolina
United States	Sleep-Wake Disorder Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Puerto Rico,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes