Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Sleep Apnea, Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078312
• Other study ID #: C10953/3023/ES/MN
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2004
• Last updated: July 12, 2013
• Start date: January 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: July 2006
• Est. primary 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:

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

Study Design

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

Related Conditions & MeSH terms

• Apnea
• Disease
• Narcolepsy
• Parasomnias
• Shift-Work Sleep Disorder
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm
• Syndrome

Intervention

Drug:
• CEP-10953 (Armodafinil)
Armodafinil (po) 100 to 250 mg/day up to 12 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as Measured by Number of Participants With Adverse Events	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.	Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter	Yes