CompletedPhase 4

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

United States396 participantsStarted 2019-09-18

Plain-language summary

The main aim of this study is learn more about long-term TAK-503 treatment in children and teenagers with ADHD for whom earlier stimulant treatment did not work. The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo and in Part B TAK-503 tablets.

Who can participate

Age range6 Years – 17 Years

SexALL

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Exclusion criteria

✕. Post-traumatic stress disorder (PTSD)
✕. Bipolar illness, psychosis, or family history in either biological parent
✕. Pervasive developmental disorder
✕. Obsessive-compulsive disorder (OCD)
✕. Psychosis/schizophrenia
✕. Serious tic disorder or a family history of Tourette's disorder

What they're measuring

Part A: Change From Baseline in the Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI) Task at Week 18

Timeframe: At Baseline, Week 18

Part A: Change From Baseline in the CANTAB RTI Task at Week 49

Timeframe: At Baseline, Week 49

Part B: Change From Baseline in the CANTAB RTI Task at Week 49

Timeframe: At Baseline, Week 49

Trial details

NCT IDNCT04085172

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-02

Results submitted2026-02-20

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials