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
  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:


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
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, see Learn About Clinical Studies.

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 July 29, 2014