Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
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
1 other identifier
interventional
36
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2010
Shorter than P25 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 4, 2011
June 1, 2011
8 months
April 26, 2010
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Laboratory Tests
Baseline period to end of 1-week treatment period.
ECG
Baseline period to end of 1-week treatment period.
Adverse Events
Baseline period till 30 days after the last dose.
Vital Signs
Baseline period to end of 1-week treatment period.
Secondary Outcomes (1)
Maintenance Wakefulness Test
Baseline period to end of 1-week treatment period.
Study Arms (3)
Arm 1
EXPERIMENTALABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Arm 2
EXPERIMENTALABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Arm 3
EXPERIMENTALABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (5)
Site Reference ID/Investigator# 43241
Phoenix, Arizona, 85006, United States
Site Reference ID/Investigator# 38092
Glendale, California, 91206, United States
Site Reference ID/Investigator# 43264
San Diego, California, 92103, United States
Site Reference ID/Investigator# 40402
New York, New York, 10019, United States
Site Reference ID/Investigator# 38122
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 26, 2010
First Posted
May 17, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 4, 2011
Record last verified: 2011-06