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Study to Evaluate the Effects of Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance in Adults With OSAHS Who Use nCPAP Therapy
This study has been completed.
First Received: July 8, 2008   Last Updated: November 11, 2009   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00711516
  Purpose

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.


Condition Intervention Phase
Excessive Sleepiness
Drug: Armodafinil
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of the Effects of Armodafinil (200 mg/Day) Treatment on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • fMRI activation volume in DLPFC (number of voxels meeting predefined threshold) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response latency on the 2-back working memory test. [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • CANTAB, ESS, CGI-C, and MOS-CF6 assessments [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Armodafinil treatment (200 mg/day)
Drug: 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.
2: Placebo Comparator 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711516

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Stanford University
Stanford, California, United States, 94305
Peninsula Sleep Center
Burlingame, California, United States, 94010
Pacific Research
San Diego, California, United States, 92103
United States, Massachusetts
Beth Israel Deaconess Medical
Boston, Massachusetts, United States, 12215
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Cephalon ( Sponsor's Medical Expert )
Study ID Numbers: C10953/4026/AP/US
Study First Received: July 8, 2008
Last Updated: November 11, 2009
ClinicalTrials.gov Identifier: NCT00711516     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Apnea Syndromes
Sleep Disorders
Apnea
Physiological Effects of Drugs
Respiration Disorders
Nervous System Diseases
Dyssomnias
Central Nervous System Stimulants
Disorders of Excessive Somnolence
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Modafinil
Respiratory Tract Diseases
Mental Disorders
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009