Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00686933
Other study ID # M10-425
Secondary ID
Status Completed
Phase Phase 2
First received May 28, 2008
Last updated January 11, 2013
Start date May 2008
Est. completion date October 2008

Study information

Verified date January 2013
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
ABT-089
Subjects will take up to 80 mg daily for 24 months

Locations

Country Name City State
United States Site Reference ID/Investigator# 8305 Bellevue Washington
United States Site Reference ID/Investigator# 8309 Eugene Oregon
United States Site Reference ID/Investigator# 8307 Farmington Hills Michigan
United States Site Reference ID/Investigator# 8306 Jacksonville Florida
United States Site Reference ID/Investigator# 8315 Lafayette California
United States Site Reference ID/Investigator# 8310 Memphis Tennessee
United States Site Reference ID/Investigator# 8308 Orlando Florida
United States Site Reference ID/Investigator# 8314 Overland Park Kansas
United States Site Reference ID/Investigator# 8316 Portland Oregon
United States Site Reference ID/Investigator# 8320 Seattle Washington
United States Site Reference ID/Investigator# 8318 Troy Michigan
United States Site Reference ID/Investigator# 8319 Virginia Beach Virginia

Sponsors (1)

Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CAARS:Inv Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 No
Primary CGI-ADHD-S Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 No
Secondary CAARS:Self Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 No
Secondary BRIEF-A Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 No
Secondary AAQOL Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 No
Secondary WPAI Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 No
Secondary FTND Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 No
See also
  Status Clinical Trial Phase
Completed NCT02251743 - Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD N/A
Completed NCT02226445 - Treatment Drop-out and Missed Appointments Among Adults With ADHD N/A
Completed NCT01342445 - Effects of LDX on Functioning of College Students With ADHD Phase 4
Not yet recruiting NCT00391495 - Inflammation in Children With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00528697 - A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00494819 - Validity of ADHD Subtypes Using Neuropsychological Measure N/A
Completed NCT02217371 - Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity N/A
Completed NCT01081132 - Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl Phase 3
Completed NCT06064942 - Multiple Family Narrative Therapy for Chinese Families of Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00391729 - A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00191048 - Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD Phase 4
Terminated NCT00554385 - A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT00997984 - Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study) Phase 3
Not yet recruiting NCT05568446 - Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD N/A
Completed NCT02096952 - Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD Phase 4
Recruiting NCT02623114 - Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers Phase 4
Completed NCT01351246 - Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD) N/A
Completed NCT00491647 - Time Perception Deficits and Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT01081145 - Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD) Phase 3
Recruiting NCT06185985 - Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms Phase 4