A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss

Shire1 site in 1 country135 target enrollmentApril 5, 2010

ConditionsSleep Deprivation

InterventionsSPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil Placebo

DrugsSPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil Placebo

Overview

Phase: Phase 2
Intervention: SPD489 20 mg
Conditions: Sleep Deprivation
Sponsor: Shire
Enrollment: 135
Locations: 1
Primary Endpoint: Maintenance of Wakefulness Test (MWT)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.

Registry

clinicaltrials.gov

Start Date

April 5, 2010

End Date

July 18, 2010

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male subjects between the ages of 18-40 years.
•The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
•Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
•Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria

•Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
•Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
•Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) \>10.

Arms & Interventions

SPD489 20 mg

Intervention: SPD489 20 mg

SPD489 50 mg

Intervention: SPD489 50 mg

SPD489 70 mg

Intervention: SPD489 70 mg

Armodafinil

Intervention: Armodafinil

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Maintenance of Wakefulness Test (MWT)

Time Frame: Over a period of 8 hours

The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.