Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00686933
First received: May 28, 2008
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention-Deficit/Hyperactivity Disorder |
Drug: ABT-089 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study for Subjects Completing Study M10-346 |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- CAARS:Inv [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- CGI-ADHD-S [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CAARS:Self [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- BRIEF-A [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- AAQOL [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- WPAI [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- FTND [ Time Frame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
| Enrollment: | 117 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ABT-089
Subjects will take up to 80 mg daily for 24 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subject was randomized into Study M10-346 and completed the study.
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- Male subjects must agree to comply with applicable contraceptive requirements.
- The subject is judged to be in generally good health.
Exclusion Criteria:
- The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.
- The subject anticipates a move outside the geographic area.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686933
Locations
| United States, California | |
| Site Reference ID/Investigator# 8315 | |
| Lafayette, California, United States, 94549 | |
| United States, Florida | |
| Site Reference ID/Investigator# 8306 | |
| Jacksonville, Florida, United States, 32216 | |
| Site Reference ID/Investigator# 8308 | |
| Orlando, Florida, United States, 32806 | |
| United States, Kansas | |
| Site Reference ID/Investigator# 8314 | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Michigan | |
| Site Reference ID/Investigator# 8307 | |
| Farmington Hills, Michigan, United States, 48336 | |
| Site Reference ID/Investigator# 8318 | |
| Troy, Michigan, United States, 48085 | |
| United States, Oregon | |
| Site Reference ID/Investigator# 8309 | |
| Eugene, Oregon, United States, 97401 | |
| Site Reference ID/Investigator# 8316 | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Site Reference ID/Investigator# 8310 | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Virginia | |
| Site Reference ID/Investigator# 8319 | |
| Virginia Beach, Virginia, United States, 23452 | |
| United States, Washington | |
| Site Reference ID/Investigator# 8305 | |
| Bellevue, Washington, United States, 98007 | |
| Site Reference ID/Investigator# 8320 | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Earle Bain, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00686933 History of Changes |
| Other Study ID Numbers: | M10-425 |
| Study First Received: | May 28, 2008 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Attention-Deficit/Hyperactivity Disorder |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013