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

Sleep Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124851
• Other study ID #: M11-685
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2010
• Last updated: June 30, 2011
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Disorders

Intervention

Drug:
• ABT-652
See arm description for details
• Placebo
See arm description for details

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 38122	Durham	North Carolina
United States	Site Reference ID/Investigator# 38092	Glendale	California
United States	Site Reference ID/Investigator# 40402	New York	New York
United States	Site Reference ID/Investigator# 43241	Phoenix	Arizona
United States	Site Reference ID/Investigator# 43264	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory Tests		Baseline period to end of 1-week treatment period.	Yes
Primary	ECG		Baseline period to end of 1-week treatment period.	Yes
Primary	Adverse Events		Baseline period till 30 days after the last dose.	Yes
Primary	Vital Signs		Baseline period to end of 1-week treatment period.	Yes
Secondary	Maintenance Wakefulness Test		Baseline period to end of 1-week treatment period.	No