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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01124851
• Collaborator: (none)
• Enrollment: 36
• Locations: 5
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder	Drug: ABT-652; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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; Drug: Placebo; See arm description for details
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; Drug: Placebo; See arm description for details
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; Drug: Placebo; See arm description for details

Outcome Measures

Primary Outcome Measures

1. Laboratory Tests [Baseline period to end of 1-week treatment period.]

2. ECG [Baseline period to end of 1-week treatment period.]

3. Adverse Events [Baseline period till 30 days after the last dose.]

4. Vital Signs [Baseline period to end of 1-week treatment period.]

Secondary Outcome Measures

1. Maintenance Wakefulness Test [Baseline period to end of 1-week treatment period.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 43241	Phoenix	Arizona	United States	85006
2	Site Reference ID/Investigator# 38092	Glendale	California	United States	91206
3	Site Reference ID/Investigator# 43264	San Diego	California	United States	92103
4	Site Reference ID/Investigator# 40402	New York	New York	United States	10019
5	Site Reference ID/Investigator# 38122	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01124851
• Other Study ID Numbers: M11-685
• First Posted: May 17, 2010
• Last Update Posted: Jul 4, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Sleep disorder
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Disorders of Excessive Somnolence; Sleepiness

Study Results

No Results Posted as of Jul 4, 2011