Guanfacine hydrochloride (TAK-503) for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Attention Deficit Hyperactivity Disorder (ADHD)+2 More
Guanfacine hydrochloride (TAK-503) - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Part A: Baseline, Week 10, Week 18, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52 Part B: Baseline, Week 10, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52

Week 52
Columbia- Suicide Severity Rating Scale (CSSRS)
Baseline, Week 10
Neuropsychological Tests
Baseline, Week 18
Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18
Baseline, Week 49
Change From Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49
Week 53
Number of Participants With Clinically Significant Changes in Vital signs, ECG, Physical Examination
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Week 49
ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales
Week 49
Brief Psychiatric Rating Scale for Children (BPRS-C)
Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF)
Conners 3 Parent Short Form (C3PS) Total Score
Pediatric Daytime Sleepiness Scale (PDSS)
Week 52
Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Week 49
Change From Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points
Neuropsychological Tests
Change From Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points
Neuropsychological Tests
Tanner Stage in Both Part A and Part B at Specified Time Points
Week 49
Clinical Global Impression-Improvement (CGI-I)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Part A: Atomoxetine hydrochloride
1 of 4
Part A: Guanfacine hydrochloride (TAK-503)
1 of 4
Part B: Guanfacine hydrochloride (TAK-503)
1 of 4
Part A: Placebo
1 of 4

Active Control

Experimental Treatment

Non-Treatment Group

288 Total Participants · 4 Treatment Groups

Primary Treatment: Guanfacine hydrochloride (TAK-503) · Has Placebo Group · Phase 4

Part A: Guanfacine hydrochloride (TAK-503)
Drug
Experimental Group · 1 Intervention: Guanfacine hydrochloride (TAK-503) · Intervention Types: Drug
Part B: Guanfacine hydrochloride (TAK-503)
Drug
Experimental Group · 1 Intervention: Guanfacine hydrochloride (TAK-503) · Intervention Types: Drug
Part A: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Part A: Atomoxetine hydrochloride
Drug
ActiveComparator Group · 1 Intervention: Atomoxetine hydrochloride · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: part a: baseline, week 10, week 18, week 23, week 36, week 49, week 50, week 51 and week 52 part b: baseline, week 10, week 23, week 36, week 49, week 50, week 51 and week 52

Who is running the clinical trial?

Takeda Development Center Americas, Inc.Industry Sponsor
46 Previous Clinical Trials
10,986 Total Patients Enrolled
ShireLead Sponsor
455 Previous Clinical Trials
92,558 Total Patients Enrolled
71 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
10,945 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Study DirectorStudy DirectorTakeda Development Center Americas
1,058 Previous Clinical Trials
473,727 Total Patients Enrolled
43 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
11,094 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have supine and standing BP measurements less than the 95th percentile for age, sex, and height at both screening (Visit 1A) and baseline (Visit 2A).
You are a male or female aged 6 to 17 years inclusive at the time of consent/assent.
Parent/LAR must be willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Wisconsin18.2%
Texas18.2%
Nevada9.1%
Other54.5%
How old are they?
18 - 6590.9%
< 189.1%
What site did they apply to?
Care Research Center, Inc.14.3%
AMR Conventions Research14.3%
Phoenix Medical Research, Inc.14.3%
Other57.1%
What portion of applicants met pre-screening criteria?
Met criteria72.7%
Did not meet criteria27.3%

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email100.0%
Most responsive sites:
  1. Center for Psychiatry and Behavioral Medicine, Inc.: < 24 hours