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Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01096680
First received: March 30, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Deprivation
 Drug: SPD489 20 mg
Drug: SPD489 50 mg
Drug: SPD489 70 mg
Drug: Armodafinil
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Maintenance of Wakefulness Test (MWT) [ Time Frame: Over a period of 8 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Karolinska Sleepiness Scale (KSS) Scores [ Time Frame: Over a period of 15 hours ] [ Designated as safety issue: No ]
    The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.

  • KSS Scores by Timepoint [ Time Frame: Over a period of 15 hours ] [ Designated as safety issue: No ]
    The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.

  • Psychomotor Vigilance Task (PVT) Scores [ Time Frame: Over a period of 12 hours ] [ Designated as safety issue: No ]
    PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.

  • PVT Scores by Timepoint [ Time Frame: Over a period of 12 hours ] [ Designated as safety issue: No ]
    PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.


Enrollment: 135
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 20 mg Drug: SPD489 20 mg
Single oral dose of 20 mg
Other Name: Vyvanse
Experimental: SPD489 50 mg Drug: SPD489 50 mg
Single oral dose of 50 mg
Other Name: Vyvanse
Experimental: SPD489 70 mg Drug: SPD489 70 mg
Single oral dose of 70 mg
Other Name: Vyvanse
Active Comparator: Armodafinil Drug: Armodafinil
Single oral dose of 250 mg
Placebo Comparator: Placebo Drug: Placebo
Single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096680

Locations
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
Sponsors and Collaborators
Shire Development LLC
Investigators
Principal Investigator: Jon Freeman, PhD Clinilabs, Inc.
  More Information

No publications provided

Responsible Party: Shire Development LLC
ClinicalTrials.gov Identifier: NCT01096680     History of Changes
Other Study ID Numbers: SPD489-207
Study First Received: March 30, 2010
Results First Received: May 25, 2011
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Modafinil
 Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013