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New treatment option for Attention Deficit Hyperactivity Disorder (ADHD)
Official title A Long-term Trial of EB-1020 in Adult Patients With ADHD
ClinicalTrials.gov ID: NCT06926829
What this study is testing
What is EB-1020 (Centanafadine) 164.4 mg?
EB-1020 (Centanafadine) 164.4 mg 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 safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Participants who completed the treatment period andfollow-up period in the preceding blinded parent Trial (Trial 405-102-00112) and did not meet the...
- Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding blinded parent...
You likely can't join if
- Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
- Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the...
- Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following...
- Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version...
- Reported suicidal behavior
- Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding blinded parent trial.
See the full eligibility criteria
- Participants who completed the treatment period andfollow-up period in the preceding blinded parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product...
- Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding blinded parent trial.
- Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
- Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed...
- 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 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding...
- Reported suicidal behavior
- Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding blinded parent trial.
- Participants who test positive for drugs or alcohol in a urine test on baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo, 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 study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo, 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.