Status:
COMPLETED
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
Lead Sponsor:
Cephalon
Conditions:
Excessive Sleepiness
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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/Hypop...
Eligibility Criteria
Inclusion
- 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
- 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 Any woman becoming pregnant during the study will be withdrawn from the study.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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00711516
Start Date
September 1 2008
End Date
October 1 2009
Last Update
July 19 2013
Active Locations (9)
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1
Peninsula Sleep Center
Burlingame, California, United States, 94010
2
Pacific Research
San Diego, California, United States, 92103
3
VA San Diego Healthcare System
San Diego, California, United States, 92161
4
Stanford University
Stanford, California, United States, 94305