Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)

NCT00078325 | Completed Phase 3 Results

• 1 other identifier: C10953/3021/AP/MN
• Study Type: interventional
• Target: 395
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.

Conditions

Obstructive Sleep Apnea; Hypopnea

Keywords

Excessive Sleepiness; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Cephalon; Cephalon, Inc; NUVIGIL

Outcome Measures

Primary Outcomes (2)

• Maintenance of Wakefulness Test (MWT)

  The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.

  change from baseline at 12 weeks

• Clinical Global Impression of Change (CGI-C)

  The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

  change from baseline at 12 weeks

Study Arms (3)

1

EXPERIMENTAL

Armodafinil 250 mg/day

Drug: Armodafinil 250 mg/day

2

EXPERIMENTAL

Armodafinil 150 mg/day

Drug: Armodafinil 150 mg/day

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Armodafinil 250 mg/day DRUG

Armodafinil 250 mg once daily in the morning

Also known as: NUVIGIL, CEP-10953

1

Armodafinil 150 mg/day DRUG

Armodafinil 150 mg once daily in the morning

Also known as: NUVIGIL, CEP-10953

2

Placebo DRUG

Matching placebo tablets once daily in the morning

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are included in the study if all of the following criteria are met:
• Written informed consent is obtained.
• The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
• The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
• The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
• The patient meets the following nCPAP therapy requirements:
• 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 shown to be effective, with effectiveness defined as having an apnea-hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy.
• Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2-week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights).
• The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
• Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using 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 \[IUD\]) and agree to continued use of this method for the duration of the study.
• The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more.
• The patient has an ESS score of 10 or more.
• The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.

You may not qualify if:

• Patients are excluded from participating in this study if 1 or more of the following criteria are met:
• has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
• has a probable diagnosis of a current sleep disorder other than OSAHS
• consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day
• used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the second screening visit
• has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV)
• has a positive urine drug screen (UDS)
• has a clinically significant deviation from normal in the physical examination
• is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
• has used an investigational drug within 1 month before the initial screening visit
• has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
• has a known clinically significant drug sensitivity to stimulants or modafinil

Sponsors & Collaborators

• Cephalon: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Sponsor's Medical Director, Clinical Research
• Organization: Cephalon

1-877-237-4879

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2004
• First Posted: February 25, 2004
• Study Start: February 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: July 19, 2013
• Results First Posted: July 29, 2010

Record last verified: 2013-07