Clinical trial NCT00228553: Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Excessive Daytime Sleepiness
Narcolepsy
Obstructive Sleep Apnea/Hypopnea Syndrome
Chronic Shift Work Sleep Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
timeFrame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Ctr of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Phoenix
country: United States
facility: Psypharma Clinical Research
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Ins
state: California
city: Beverly Hills
country: United States
facility: Southwestern Research
state: California
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Service
state: California
city: Palm Springs
country: United States
facility: Pacific Sleep Medicine Service
state: California
city: San Diego
country: United States
facility: Radiant Research San Diego
state: California
city: San Diego
country: United States
facility: Pacific Sleep Medicine Service
state: California
city: San Diego
country: United States
facility: BMR HealthQuest
state: California
city: San Francisco
country: United States
facility: Sleep Clinic of San Francisco
state: California
city: Santa Monica
country: United States
facility: St. Johns Medical Plaza Sleep
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: St. Petersburg
country: United States
facility: St. Petersburg Sleep Disorder
state: Florida
city: Winter Park
country: United States
facility: Sleep-Wake Disorder Center
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of GA
state: Georgia
city: Macon
country: United States
facility: SLEEPMED, Inc.
state: Georgia
city: Marietta
country: United States
facility: Radiant Research Marietta
state: Georgia
city: Northfield
country: United States
facility: Henry Lahmeyer, MD
state: Illinois
city: Peoria
country: United States
facility: Peoria Pulmonary Associates
state: Illinois
city: Danville
country: United States
facility: Center for Sleep Disorders
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Overland Park
country: United States
facility: Vince and Associates Clinical
state: Kansas
city: Topeka
country: United States
facility: Topeka Pulmonary
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Crestview
country: United States
facility: Community Research
state: Kentucky
city: Louisville
country: United States
facility: Chest Medicine Associates DBA
state: Kentucky
city: Metairie
country: United States
facility: Neurotrials Research of New Or
state: Louisiana
city: Slidell
country: United States
facility: Northshore Research Associates
state: Louisiana
city: Chevy Chase
country: United States
facility: Center for Sleep/Wake Disorder
state: Maryland
city: Elkton
country: United States
facility: Regional Pulmonary and Sleep
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Hattiesburg
country: United States
facility: Sleep Disorders Center
state: Mississippi
city: St. Louis
country: United States
facility: Washington University School o
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Rsch Center of Nevada
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Clinilabs / Sleep Disorders In
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Vital re:Search
state: North Carolina
city: Hickory
country: United States
facility: Neurology Associates of Hickor
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: Central Carolina Neurology Sle
state: North Carolina
city: Winston-Salem
country: United States
facility: All Trials Clinical Research
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Beechwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Community Research Management
state: Ohio
city: Cincinnati
country: United States
facility: Tri State Sleep Disorders Cent
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Dept Veterans Affairs Dayton
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine-Neurosci
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Cleveland Sleep Cent
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Cent
state: Ohio
city: Tulsa
country: United States
facility: Clinical Pharmaceutical Trials
state: Oklahoma
city: Carlisle
country: United States
facility: Capital Region Sleep Disorders
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Consolidated Clinical Trials
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Lung and Critical
state: South Carolina
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Sleep Disorders Cen
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: Sleep Medicine Institute
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: Houston
country: United States
facility: VA Medical CenterSleep Diagnos
state: Texas
city: The Woodlands
country: United States
facility: Sadler Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospit
state: Virginia
city: Seattle
country: United States
facility: Swedish Sleep Medicine Institute
state: Washington
city: Wauwatosa
country: United States
facility: Allegiance Research Specialist
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Center
state: Victoria
city: East Melbourne
country: Australia
facility: Melbourne Sleep Disorders Ctr.
state: Victoria
city: Calgary
country: Canada
facility: Canadian Sleep Institute
state: Alberta
city: Kitchener
country: Canada
facility: Sleep Clinic
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Clinical Research
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Parry Sound
country: Canada
facility: West Parry Sound Health Center
state: Ontario
city: Scarborough
country: Canada
facility: Sleep and Neuropsychiatry Cent
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Hospital
state: Ontario
city: Montpellier
country: France
facility: Hopital Guy de Chauliac
state: Cedex 05
city: Strasbourg
country: France
facility: Universitaires de Strasbourg
state: Cedex
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Creteil
country: France
facility: Hospital Henri-Mondor
city: Freiburg
country: Germany
facility: University of Freiburg
city: Marburg
country: Germany
facility: Klinikum der Philipps
city: Regensburg
country: Germany
facility: University of Regensburg
city: Schwalmstadt
country: Germany
facility: Hephata Klinik
city: San Juan
country: Puerto Rico
facility: SomniCare Sleep Institute
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 33
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 83
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital Russian Scie
city: Samara
country: Russian Federation
facility: Multifunction Center of Neurol
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Director, MD
role: STUDY_DIRECTOR
References: