TAK-503 for ADHD

Recruiting in Palo Alto (17 mi)

+75 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Shire

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children and teenagers aged 6 to 17 with ADHD who haven't responded well to stimulant therapy. They must have an intellectual function appropriate for their age, a certain score on the ADHD rating scale, and normal blood pressure. Those with heart issues, allergies to study drugs, or other significant health problems are excluded.

Inclusion Criteria

Your score on the ADHD-RS-5 test is 28 or higher at the start of the study.

Study Part B: Female participants of child-bearing potential must have a negative serum β-hCG pregnancy test if a screening visit is conducted and/or a negative urine pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol.

I am between 6 and 17 years old.

+18 more

Exclusion Criteria

You have experienced physical, sexual, or emotional abuse.

Study Part A: Participant has any condition or illness including any clinically significant abnormal laboratory value at screening or baseline that, as judged by the investigator, would be an inappropriate risk to the participant and/or could confound the interpretation of study results.

Study Part A: Participant is significantly overweight based on the CDC BMI-for-age sex-specific charts at screening or baseline.

+31 more

Participant Groups

The trial tests TAK-503 against atomoxetine and placebo in kids and teens with ADHD over two parts. In Part A, participants randomly receive one of the three treatments; those on placebo then get TAK-503 in Part B while others continue on TAK-503.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part B: Guanfacine hydrochloride (TAK-503)Experimental Treatment1 Intervention

Participants from Part A will roll over into Part B directly after 18 weeks and will receive TAK-503 at an initial dose of 1 mg, and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablet QD for 52 weeks of Part B.

Group II: Part A: Guanfacine hydrochloride (TAK-503)Experimental Treatment1 Intervention

Participants randomized to TAK-503 will receive initial dose of 1 milligram (mg), and up titrated with weekly incremental dose of 1 mg until an optimal dose is reached. Participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablet once daily (QD) for 18 weeks.

Group III: Part A: Atomoxetine hydrochlorideActive Control1 Intervention

Participants who weigh less than (\<) 70 kilograms (kg) at baseline will receive Atomoxetine hydrochloride capsule orally at an initial dose of 0.5 milligram per kilogram (mg/kg) which may be increased to the target dose of 1.2 mg/kg oral capsule QD during the treatment of 18 weeks. Permitted doses of Atomoxetine hydrochloride capsule will be 10, 18, 25, 40, 60, and 80 mg QD. Participants who weigh \>= 70 kg at baseline will receive Atomoxetine hydrochloride at an initial dose of 40 mg oral capsule QD which may be increased to 80 mg and then to 100 mg for 18 weeks. The total dose for participants who weigh \>= 70 kg at baseline will not exceed 100 mg.

Group IV: Part A: PlaceboPlacebo Group1 Intervention

Participants aged 6 to 12 years will receive a dose of 1 to 4 mg tablet of placebo matched to TAK-503 and aged 13 to 17 years will receive a dose of 5 to 7 mg tablets of placebo matched to TAK-503 orally QD for 18 weeks. Participants who weigh \< 70 kg at baseline will receive placebo matched to Atomoxetine hydrochloride oral capsule at an initial dose of 0.5 mg/kg which may be increased to the target dose of 1.2 mg/kg QD oral capsule during the treatment of 18 weeks. Permitted doses of placebo matched to Atomoxetine hydrochloride will be 10, 18, 25, 40, 60, and 80 mg QD and participants who weigh \>= 70 kg will receive placebo matched to Atomoxetine hydrochloride at an initial dose of 40 mg QD capsule orally which may be increased to 80 mg and then to 100 mg.