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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: Armodafinil; Modafinil

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.