Clinical trial NCT00078312: Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Official title: A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Study of the Safety and Efficacy of 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: Narcolepsy
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Shift-Work Sleep Disorder
Keywords: Excessive Sleepiness
Narcolepsy
Cataplexy
Sleep Attacks
Obstructive Sleep Apnea
Obstructive Sleep Hypopnea
nCPAP
Chronic Shift Work Sleep Disorder
Chronic SWSD
Circadian Rhythm Disorder
Shift Worker
Cepahlon
Cephalon, Inc
Nuvigil
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2004-02-25
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).


Eligibility criteria: Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

1. Written informed consent is obtained.
2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
3. The patient has a complaint of excessive sleepiness associated with a current diagnosis of:

   * Narcolepsy-Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.
   * OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:

     * Previous adequate education and intervention efforts to encourage nCPAP therapy use must be documented.
     * A patient's nCPAP therapy regimen must be stable for at least 4 weeks.
     * nCPAP therapy is effective, in the opinion of the investigator.
     * Evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of the nights).
   * Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study.
4. The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.)
5. The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. 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 \[IUD\]).
6. The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments.
7. 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:

1. have any clinically significant, uncontrolled medical conditions (treated or untreated)
2. have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD
3. consume caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine or more than 8 cups of coffee per day
4. used any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before the baseline visit
5. 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)
6. have a positive UDS at the screening visit
7. have a clinically significant deviation from normal in the physical examination
8. are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study
9. have used an investigational drug within 1 month before the screening visit
10. have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
11. have a known clinically significant drug sensitivity to stimulants

Primary outcomes:
measure: Safety and Tolerability as Measured by Number of Participants With Adverse Events
timeFrame: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic, LLC
state: Arizona
city: Tucson
country: United States
facility: Radiant Research - Tucson
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Lafayette
country: United States
facility: Bay Area Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics Inc.
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: Synergy Clinical Research Center
state: California
city: San Diego
country: United States
facility: BMR HealthQuest Clinical Trials
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Therafirst Medical Centers
state: Florida
city: Hallandale
country: United States
facility: Precision Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: St. Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Boise
country: United States
facility: Radiant Research, Boise
state: Idaho
city: Chicago
country: United States
facility: Herron Medical Center, Ltd.
state: Illinois
city: Chicago
country: United States
facility: Radiant Research, Chicago
state: Illinois
city: Elk Grove Village
country: United States
facility: Radiant Research Alexian Brothers
state: Illinois
city: Northfield
country: United States
facility: Henry W. Lahmeyer, MD and Associates
state: Illinois
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Metairie
country: United States
facility: NeuroTrials Research of New Orleans, LLC
state: Louisiana
city: Frederick
country: United States
facility: Marc Raphaelson, MD, PA
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head-Pain Neurological Institute
state: Michigan
city: Lincoln
country: United States
facility: Somnos Laboratories, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute, PC
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Beachwood
country: United States
facility: North Coast Clinical Trials, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Clinical Research Studies
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital Hospital
state: Pennsylvania
city: Pottstown
country: United States
facility: Center for Sleep Disorders, Inc.
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Radiant Research, San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Moscow
country: Russian Federation
facility: Institute of Pulmonology
city: Moscow
country: Russian Federation
facility: Moscow City Somnological Center
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No. 83
city: Moscow
country: Russian Federation
facility: United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No. 81
city: Moscow
country: Russian Federation
facility: Center of Rehabilitation of Presidential Medical Center
city: Saint Petersburg
country: Russian Federation
facility: Cardioclinic
city: Saint Petersburg
country: Russian Federation
facility: Clinic of Neurology and Neurosurgery of Saint Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: Medical Sanitary Unit No. 122 of Saint-Petersburg
Study officials:
References: