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Tests treatment safety and results for Attention-Deficit Hyperactivity Disorder(ADHD)
Official title A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
ClinicalTrials.gov ID: NCT07086313
What this study is testing
What is EB-1020 (Centanafadine) low dose?
EB-1020 (Centanafadine) low dose is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for attention-deficit hyperactivity disorder(adhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID...
- Participants with a symptom total raw score of\>=28 (if not receiving any pharmacological treatment for ADHD) or\>=22 (if receiving pharmacological...
- Participants with a symptom total raw score of\>=28 on the ADHD-RS-5 at baseline.
- Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.
You likely can't join if
- Participants who have a positive pregnancy test result at baseline.
- Participants determined to have the following diseases based on an interview using the MINI-KID.
- Tourette's disorder
- Panic disorder
- Conduct disorder
- Psychotic disorder
See the full eligibility criteria
- Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.
- Participants with a symptom total raw score of\>=28 (if not receiving any pharmacological treatment for ADHD) or\>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at...
- Participants with a symptom total raw score of\>=28 on the ADHD-RS-5 at baseline.
- Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.
- Participants who have a positive pregnancy test result at baseline.
- Participants determined to have the following diseases based on an interview using the MINI-KID.
- Tourette's disorder
- Panic disorder
- Conduct disorder
- Psychotic disorder
- Post-traumatic stress disorder
- Bipolar disorder
- Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.
- Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.
- Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.
- Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months...
- Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.
- Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.
- Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the...
- Participants with a diagnosis of substance use disorder.
- Platelets \<= 130,000/mm3
- Hemoglobin \<= 11.2 g/dL
- Neutrophils, absolute \<= 1000/mm3
- AST \> 2 x ULN
- ALT \> 2 x ULN
- eGFR \< 45 mL/min/1.73 m2, calculated by the CKiD U25 equation
- CPK \>= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator)
- Abnormal values for both free T4 and TSH
- Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
The study team makes the final eligibility decision.
Where it's taking place
- Sapporo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sapporo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.