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Norepinephrine Reuptake Inhibitor

TAK-503 for ADHD

Phase 4

Waitlist Available

Research Sponsored by Shire

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study Part A: Participant is a male or female aged 6 to 17 years inclusive at the time of consent/assent.

Study Part A: Participant must meet DSM-5 criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation using the K-SADS-PL by a trained child and adolescent psychiatrist at screening (Visit 1A).

Must not have

Study Part B: Participant had any clinically significant TEAE during Study Part A that would preclude exposure to TAK-503.

Study Part B: Participant currently uses any of the prohibited medication or other medications in violation of the protocol-specified washout criteria at baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: baseline, week 10, week 18 part b: baseline, week 10, week 23, week 36, week 49, week 50, week 51 and week 52

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is studying a new medication for children and teenagers with ADHD who haven't responded well to other stimulant medications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include sleepiness, headache, stomach pain, nausea, dizziness, mood swings and potentially low blood pressure. The exact side effects will vary between individuals based on their reaction to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

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I have been diagnosed with ADHD by a psychiatrist.

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My blood pressure, both lying down and standing, is within normal range for my age, sex, and height.

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My blood pressure is below the high range for my age, sex, and height.

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I am between 6 and 17 years old.

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My blood pressure is below the high range for my age, sex, and height.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experienced severe side effects in the first part of the study that would prevent me from safely taking TAK-503.

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I am not using any medication that the study prohibits.

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I have a history of serious heart issues.

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I am allergic or intolerant to guanfacine, atomoxetine, or any component of TAK-503.

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I have a history of serious heart issues or events related to exercise.

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I am a pregnant or breastfeeding woman.

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I have a psychiatric disorder, but it's not oppositional defiant disorder.

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I have low blood pressure when standing or a history of high blood pressure.

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I am either a child 6-12 years under 25kg or a teen 13+ years under 34kg.

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I am taking medication for a condition other than ADHD that affects my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: baseline, week 10, week 18 part b: baseline, week 10, week 23, week 36, week 49, week 50, week 51 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: baseline, week 10, week 18 part b: baseline, week 10, week 23, week 36, week 49, week 50, week 51 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: baseline, week 10, week 18 part b: baseline, week 10, week 23, week 36, week 49, week 50, week 51 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Part B: Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49

Parts A and B: Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10

Secondary study objectives

Parts A and B: ADHD-Rating Scale-5 (ADHD-RS-5) Total Score and Subscales

Parts A and B: Brief Psychiatric Rating Scale for Children (BPRS-C)

Parts A and B: Change From Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Specified Time Points

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

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.

0 / 16Eligibility criteria met