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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01124851
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
Abbott

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Disorder Drug: ABT-652 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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
Drug: Placebo
See arm description for details
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
Drug: Placebo
See arm description for details
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
Drug: Placebo
See arm description for details



Primary Outcome Measures :
  1. Laboratory Tests [ Time Frame: Baseline period to end of 1-week treatment period. ]
  2. ECG [ Time Frame: Baseline period to end of 1-week treatment period. ]
  3. Adverse Events [ Time Frame: Baseline period till 30 days after the last dose. ]
  4. Vital Signs [ Time Frame: Baseline period to end of 1-week treatment period. ]

Secondary Outcome Measures :
  1. Maintenance Wakefulness Test [ Time Frame: Baseline period to end of 1-week treatment period. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hana Florian, MD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01124851     History of Changes
Other Study ID Numbers: M11-685
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Abbott:
Sleep disorder

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