Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

NCT ID: NCT00711516

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-10-31

Brief Summary

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.

Conditions

Excessive Sleepiness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Armodafinil treatment (200 mg/day) - Study drug was supplied as 50 mg tablets and the dose was titrated from a starting dose of 50 mg taken once daily in the morning (before 0800), increasing to 100 mg/day on Day 2, 150 mg/day on day 5, and then 200 mg/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

2

Placebo comparator - Placebo tablets matching the armodafinil 50 mg tablets drug were supplied and the dose was titrated from a starting dose of one tablet taken once daily in the morning (before 0800), increasing to two tablets/day on Day 2, three tablets/day on day 5, and then four tablets/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

Interventions

Armodafinil

Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

Intervention Type: DRUG

Placebo

Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has a current diagnosis of OSAHS and has a complaint of excessive sleepiness despite effective nCPAP therapy.
• Patient has excessive sleepiness as evidenced by a mean sleep latency of less than 8 minutes, as determined by the MSLT.
• Patient has an ESS score of 10 or more at the initial screening visit.
• Patient has a habitual sleep time beginning no earlier than 2100 and ending no later than 0700.
• Patient is right-handed. Patients who are ambidextrous may be eligible following consultation with the medical monitor.
• Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
• Patient exhibits reasonable accuracy (≥80%) on the 2-back working memory task during the training session at the second screening visit.

Exclusion Criteria

The Patient:

• The patient is a current smoker or has a prior history of smoking (defined as ≥1 pack-year) within 2 years prior to the screening visit.
• consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 400 mg of caffeine per day (approximately equivalent to 4 or more cups of coffee).
• has NART-predicted verbal IQ and QIDS-SR16 scores within protocol-specific exclusionary ranges.
• has a clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated).
• has a confirmed or probable diagnosis of a current sleep disorder other than OSAHS.
• has used any excluded prescription drugs or procedures for prohibited and allowed drugs within the excluded timeframe.
• has a history of alcohol, narcotic, or any other drug abuse.
• has a positive UDS, without medical explanation, at the screening visit.
• 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 a past or present seizure disorder, head trauma that is clinically significant, or past neurosurgery.
• has used an investigational drug within 1 month before the screening visit.
• has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
• has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
• has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
• has known human immunodeficiency virus (HIV).
• has clinical laboratory test value(s) outside the range(s) specified in the Protocol, or presents a clinically significant laboratory abnormality without prior written approval by the medical monitor.
• has worked the night shift within 28 days of the baseline visit, or will work the night shift during the double-blind segment of the study.
• anticipates any travel across more than 3 time zones at any time during the study.
• needs to use any of the excluded medications identified in this protocol.
• is unable to complete neuroimaging studies, performance tasks, self-rating scales, and all other study assessments.
• has a contraindication to fMRI scanning, (such as an implanted pacemaker/defibrillator, aneurysm clips, drug infusion device or metallic foreign body).
• is suspected to be unable to tolerate fMRI scanning (eg, claustrophobic) and/or the testing paradigm.
• has physical or other characteristics that suggest imaging data will be unobtainable or degraded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon

Locations

Peninsula Sleep Center

Burlingame, California, United States

Pacific Research

San Diego, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Stanford University

Stanford, California, United States

Beth Israel Deaconess Medical

Boston, Massachusetts, United States

Neurocare, Inc.

Newton, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Countries

United States

References

Greve DN, Duntley SP, Larson-Prior L, Krystal AD, Diaz MT, Drummond SP, Thein SG, Kushida CA, Yang R, Thomas RJ. Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-Treated OSA: a multicenter fMRI study. J Clin Sleep Med. 2014 Feb 15;10(2):143-53. doi: 10.5664/jcsm.3440.

Reference Type: DERIVED

PMID: 24532997 (View on PubMed)

Other Identifiers

C10953/4026/AP/US

Identifier Type: -

Identifier Source: org_study_id