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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).
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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 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 active 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.
Find a Location
Who is running the clinical trial?
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,746 Total Patients Enrolled
ShireLead Sponsor
456 Previous Clinical Trials
97,004 Total Patients Enrolled
72 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
15,953 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Study DirectorStudy DirectorTakeda Development Center Americas
1,211 Previous Clinical Trials
489,221 Total Patients Enrolled
45 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
16,935 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced physical, sexual, or emotional abuse.Your score on the ADHD-RS-5 test is 28 or higher at the start of the study.You have a problem with using drugs or alcohol, as defined by specific medical criteria.I am between 6 and 17 years old.My parent or legal guardian and I agree to follow all study requirements.I am taking medication for a condition other than ADHD that affects my brain.I experienced severe side effects in the first part of the study that would prevent me from safely taking TAK-503.You have a history of trying to harm yourself or are currently thinking about harming yourself.You have a total score of 28 or more on the ADHD Rating Scale at the beginning of the study.My intellectual functioning is appropriate for my age, as confirmed by a doctor.I have been diagnosed with ADHD by a psychiatrist.My blood pressure, both lying down and standing, is within normal range for my age, sex, and height.Your liver tests show high levels of ALT, AST, or bilirubin.Stimulant medications were not suitable or effective for me, as confirmed by my doctor.I am allergic or intolerant to guanfacine hydrochloride or any part of TAK-503.Your initial CGI-S score is 4 or higher.Your score on the CGI-S test at the beginning of the study is 4 or higher.My intellectual functioning is appropriate for my age.I am not taking ADHD medication or any other drugs that the study does not allow.My blood pressure is below the high range for my age, sex, and height.I am not using any medication that the study prohibits.Stimulant medications were not suitable or effective for me, as confirmed by my doctor.Your score on the CGI-S test at the beginning of the study is 4 or higher.I am between 6 and 17 years old.I have a history of serious heart issues.I am allergic or intolerant to guanfacine, atomoxetine, or any component of TAK-503.I have a history of serious heart issues or events related to exercise.I am a pregnant or breastfeeding woman.I have a psychiatric disorder, but it's not oppositional defiant disorder.I have low blood pressure when standing or a history of high blood pressure.I am either a child 6-12 years under 25kg or a teen 13+ years under 34kg.I can swallow pills and capsules without any issues.I have low blood pressure when standing or a history of high blood pressure.Your liver tests show high levels of ALT, AST, or bilirubin.I am a woman able to have children, not pregnant or breastfeeding, and agree to follow birth control rules.You have had cancer, are pregnant, or have a developmental delay not related to ADHD.I am taking medication for a condition other than ADHD that affects my brain.Your total score on the ADHD-RS-5 test is 28 or higher at the beginning of the study.My blood pressure is below the high range for my age, sex, and height.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Placebo
- Group 2: Part A: Atomoxetine hydrochloride
- Group 3: Part A: Guanfacine hydrochloride (TAK-503)
- Group 4: Part B: Guanfacine hydrochloride (TAK-503)
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04085172 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main goal of this experiment?
"This Baseline-Week 10 study seeks to evaluate the impact of TAK-503 on adolescents and children diagnosed with ADHD, by measuring Change From Baseline in the Reaction Time (RTI) Task at Week 49. Secondary objectives include tracking changes from baseline for Stop Signal Task (SST) and Rapid Visual Information Processing (RVP), as well as Brief Psychiatric Rating Scale for Children (BPRS-C). The SST task is used to measure response inhibition; participants must respond to an arrow stimulus while ignoring any accompanying audio tones. Simultaneously, RVP evaluates sustained attention over time, testing a participant's ability to detect"
Answered by AI
Who is qualified to participate in this investigation?
"This medical trial is recruiting two-hundred and eighty-eight patients, between the ages of six to seventeen years old, with an ADHD diagnosis. To qualify for this experiment, applicants must have a score higher than 28 on the Attention Deficit Hyperactivity Disorder Rating Scale 5 (ADHD-RS-5), as well as presenting a Clinical Global Impression Severity Score of four or greater at baseline. Furthermore, their blood pressure should be within normal ranges for age, sex and height measurements taken supine and standing both during screening visits and baselines tests. Lastly, participants need to demonstrate intellectual functioning appropriate for their age group when judged"
Answered by AI
What is the uppermost participant number associated with this research endeavor?
"This clinical trial, administered by Takeda Development Center Americas Inc. alongside Clinical Neuroscience Solutions in Memphis and Clinical Research Partners LLC from Petersburg requires 288 entrants to meet their criteria for inclusion."
Answered by AI
Does this clinical trial include older participants in their fifth decade or above?
"The protocol of this trial dictates that the minimum age for participation is 6 and the maximum age to be considered eligible is 17."
Answered by AI
What therapeutic applications has Guanfacine hydrochloride (TAK-503) been proven to be effective for?
"Guanfacine hydrochloride (TAK-503) is a medically useful compound, often prescribed to treat migraine. It can also prove beneficial in managing attention deficit hyperactivity disorder, hypertensive diseases and prophylactically preventing further migraine headaches."
Answered by AI
Are there any vacancies in this clinical trial for prospective participants?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially advertised on September 18th 2019, is still actively recruiting participants. There are 288 subjects needed from 23 different medical sites."
Answered by AI
Are there any precedents of research into Guanfacine hydrochloride (TAK-503)?
"At the moment, 20 clinical trials are testing the efficacy of Guanfacine hydrochloride (TAK-503), 4 of which have reached Phase 3. Locations running these studies range from Almere to California with 94 total sites offering access to TAK-503 treatment research."
Answered by AI
Does TAK-503 pose any risks to patients when administered?
"Our team at Power has rated the safety of Guanfacine hydrochloride (TAK-503) as 3 based on its Phase 4 status which indicates that it is approved."
Answered by AI
Are there multiple centers in the US that are currently conducting this investigation?
"23 medical sites are currently accepting enrollees for this trial, distributed among cities such as Memphis, Petersburg and Prairie Village. It is recommended to select the closest location in order to minimize travel costs when participating."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
Florida
Texas
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Care Research Center, Inc.
Family Psychiatry of The Woodlands
Cutting Edge Research Group, Inc
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1
Why did patients apply to this trial?
My medical insurance has put me in a bad position regarding my ADHD treatment & I don't know where else to look.
PatientReceived 2+ prior treatments
I've read a lot of RCT on ADHD and I think Guanfacine is a promising drug (in comparison with methylphenidate products and all the amphetamine types).
PatientReceived 1 prior treatment
I've read a lot of RCT on ADHD and I think Atomoxetine is a promising drug (in comparison with methylphenidate products and all the amphetamine types).
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Center for Psychiatry and Behavioral Medicine, Inc.: < 24 hours
Typically responds via
Email
Average response time
- < 1 Day
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