Skip to main content
OpenTrials
Completed

NCT Number: NCT01124851

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 43241, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-652

Drug

See arm description for details

Placebo

Drug

See arm description for details

Primary outcomes

  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 outcomes

  1. Maintenance Wakefulness Test

    Time frame: Baseline period to end of 1-week treatment period.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 17, 2010
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.