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

NCT01096680 | Completed Phase 2 Results

• 1 other identifier: SPD489-207
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• 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.

  Over a period of 8 hours

Secondary Outcomes (4)

• Karolinska Sleepiness Scale (KSS) Scores

  Over a period of 15 hours

• KSS Scores by Timepoint

  Over a period of 15 hours

• Psychomotor Vigilance Task (PVT) Scores

  Over a period of 12 hours

• PVT Scores by Timepoint

  Over a period of 12 hours

Study Arms (5)

SPD489 20 mg

EXPERIMENTAL

Drug: SPD489 20 mg

SPD489 50 mg

EXPERIMENTAL

Drug: SPD489 50 mg

SPD489 70 mg

EXPERIMENTAL

Drug: SPD489 70 mg

Armodafinil

ACTIVE COMPARATOR

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD489 20 mg DRUG

Single oral dose of 20 mg

Also known as: Vyvanse

SPD489 20 mg

SPD489 50 mg DRUG

Single oral dose of 50 mg

Also known as: Vyvanse

SPD489 50 mg

SPD489 70 mg DRUG

Single oral dose of 70 mg

Also known as: Vyvanse

SPD489 70 mg

Armodafinil DRUG

Single oral dose of 250 mg

Armodafinil

Placebo DRUG

Single oral dose

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Clinilabs, Inc.

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Lisdexamfetamine Dimesylate; Modafinil

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: April 5, 2010
• Primary Completion: July 18, 2010
• Study Completion: July 18, 2010
• Last Updated: June 14, 2021
• Results First Posted: June 23, 2011

Record last verified: 2021-06

Locations

US (1)