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

Completed · Phase 1 · Has a placebo group

Conditions studied: Sleep Disorder

In brief

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.

Key facts

Study ID

NCT01124851

Run by

Abbott

People needed

36

Starts

2010-08-01

Expected to finish

2011-04-01

Last updated by the study team

2011-07-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 43241 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 38092 — Glendale, California, United States
• Site Reference ID/Investigator# 43264 — San Diego, California, United States
• Site Reference ID/Investigator# 40402 — New York, New York, United States
• Site Reference ID/Investigator# 38122 — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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