Back to resultsPharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPD489 20 mg
SPD489 50 mg
SPD489 70 mg
Armodafinil
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sleep Deprivation
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.
Sites / Locations
- Clinilabs, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
SPD489 20 mg
SPD489 50 mg
SPD489 70 mg
Armodafinil
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Maintenance of Wakefulness Test (MWT)
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01096680
Brief Title
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 5, 2010 (Actual)
Primary Completion Date
July 18, 2010 (Actual)
Study Completion Date
July 18, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD489 20 mg
Arm Type
Experimental
Arm Title
SPD489 50 mg
Arm Type
Experimental
Arm Title
SPD489 70 mg
Arm Type
Experimental
Arm Title
Armodafinil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD489 20 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Single oral dose of 20 mg
Intervention Type
Drug
Intervention Name(s)
SPD489 50 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Single oral dose of 50 mg
Intervention Type
Drug
Intervention Name(s)
SPD489 70 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Single oral dose of 70 mg
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Intervention Description
Single oral dose of 250 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single oral dose
Primary Outcome Measure Information:
Title
Maintenance of Wakefulness Test (MWT)
Description
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.
Time Frame
Over a period of 8 hours
Secondary Outcome Measure Information:
Title
Karolinska Sleepiness Scale (KSS) Scores
Description
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.
Time Frame
Over a period of 15 hours
Title
KSS Scores by Timepoint
Description
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.
Time Frame
Over a period of 15 hours
Title
Psychomotor Vigilance Task (PVT) Scores
Description
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.
Time Frame
Over a period of 12 hours
Title
PVT Scores by Timepoint
Description
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.
Time Frame
Over a period of 12 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinilabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
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