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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01124851
First received: April 26, 2010
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.


Condition Intervention Phase
Sleep Disorder
 Drug: ABT-652
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Laboratory Tests [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Baseline period till 30 days after the last dose. ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maintenance Wakefulness Test [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
 Drug: ABT-652
See arm description for details
Other Name: ABT-652
Drug: Placebo
See arm description for details
Other Name: Placebo
Experimental: Arm 2
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
 Drug: ABT-652
See arm description for details
Other Name: ABT-652
Drug: Placebo
See arm description for details
Other Name: Placebo
Experimental: Arm 3
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
 Drug: ABT-652
See arm description for details
Other Name: ABT-652
Drug: Placebo
See arm description for details
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
  • Age 18 to 60 years Exclusion Criteria
  • Has significant suicidal ideation
  • Has a history of substance abuse
  • Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
  • Use of certain medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124851

Locations
United States, Arizona
Site Reference ID/Investigator# 43241
Phoenix, Arizona, United States, 85006
United States, California
Site Reference ID/Investigator# 38092
Glendale, California, United States, 91206
Site Reference ID/Investigator# 43264
San Diego, California, United States, 92103
United States, New York
Site Reference ID/Investigator# 40402
New York, New York, United States, 10019
United States, North Carolina
Site Reference ID/Investigator# 38122
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Hana Florian, MD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01124851     History of Changes
Other Study ID Numbers: M11-685
Study First Received: April 26, 2010
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Sleep disorder

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013