centanafadine capsule for Hyperkinesis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
For additional information regarding sites, contact 844-687-8522, New York, NY
Hyperkinesis+2 More
centanafadine capsule - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will be conducted to evaluate the efficacy of centanafadine QD XR versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.

Eligible Conditions

  • Hyperkinesis
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From baseline to week 6

Week 6
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

Weight Based Low Dose Centanafadine Capsules
1 of 3
Weight Based High Dose Centanafadine Capsules
1 of 3
Matching Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

450 Total Participants · 3 Treatment Groups

Primary Treatment: centanafadine capsule · Has Placebo Group · Phase 3

Weight Based Low Dose Centanafadine Capsules
Drug
Experimental Group · 1 Intervention: centanafadine capsule · Intervention Types: Drug
Weight Based High Dose Centanafadine Capsules
Drug
Experimental Group · 1 Intervention: centanafadine capsule · Intervention Types: Drug
Matching Placebo
Other
PlaceboComparator Group · 1 Intervention: placebo capsule · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 6
Closest Location: For additional information regarding sites, contact 844-687-8522 · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2022First Recorded Clinical Trial
9 TrialsResearching Hyperkinesis
11 CompletedClinical Trials

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
242 Previous Clinical Trials
163,546 Total Patients Enrolled
12 Trials studying Hyperkinesis
4,167 Patients Enrolled for Hyperkinesis

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have symptoms of ADHD at baseline.
You have a score of 4 or higher on the CGI-S-ADHD at baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.