Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).


Clinical Trial Description

The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.

Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.

This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.

A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed. ;


Study Design

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


Related Conditions & MeSH terms

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

NCT number NCT02163915
Study type Interventional
Source Takeda
Contact
Status Terminated
Phase Phase 1
Start date June 2014
Completion date November 2014

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
Completed NCT00528697 - A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
Not yet recruiting NCT00391495 - Inflammation in Children With Attention-Deficit/Hyperactivity Disorder N/A
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 NCT00686933 - Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2
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