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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:
ClinicalTrials.gov Identifier:
NCT01124851
First Posted: May 17, 2010
Last Update Posted: July 4, 2011
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.
Information provided by:
Abbott
  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
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

Resource links provided by NLM:


Further study details as provided by Abbott:

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

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

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Hana Florian, MD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01124851     History of Changes
Other Study ID Numbers: M11-685
First Submitted: April 26, 2010
First Posted: May 17, 2010
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