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

• ClinicalTrials.gov Identifier: NCT01096680
• Recruitment Status: Completed
• First Posted: March 31, 2010
• Results First Posted: June 23, 2011
• Last Update Posted: June 14, 2021
• Sponsor: Shire
• Information provided by (Responsible Party): Takeda ( Shire )

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.

Condition or disease	Intervention/treatment	Phase
Sleep Deprivation	Drug: SPD489 20 mg; Drug: SPD489 50 mg; Drug: SPD489 70 mg; Drug: Armodafinil; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: April 5, 2010
• Actual Primary Completion Date: July 18, 2010
• Actual Study Completion Date: July 18, 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Karolinska Sleepiness Scale (KSS) Scores [ Time Frame: Over a period of 15 hours ]
   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.
2. KSS Scores by Timepoint [ Time Frame: Over a period of 15 hours ]
   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.
3. Psychomotor Vigilance Task (PVT) Scores [ Time Frame: Over a period of 12 hours ]
   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.
4. PVT Scores by Timepoint [ Time Frame: Over a period of 12 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes 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

Locations

United States, New York

Clinilabs, Inc.

New York, New York, United States, 10019

Sponsors and Collaborators

Shire

Investigators

• Study Director: Study Director; Takeda

More Information

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01096680
• Other Study ID Numbers: SPD489-207
• First Posted: March 31, 2010
• Results First Posted: June 23, 2011
• Last Update Posted: June 14, 2021
• Last Verified: June 2021

Additional relevant MeSH terms:

Sleep Deprivation; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Lisdexamfetamine Dimesylate; Modafinil; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers