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Tests treatment safety and results for Attention Deficit Hyperactivity Disorder (ADHD)
Official title Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
ClinicalTrials.gov ID: NCT06931080
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 efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult 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 18 to 55
You may be able to join if
- Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5...
- Participants with an AISRS total score meeting the following criteria:
- Not receiving medication treatment for ADHD: 28 points or higher
- Receiving medication treatment for ADHD: 22 points or higher
You likely can't join if
- Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.
- Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this...
- Participants diagnosed with a personality disorder according to DSM-5 criteria.
- Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.
- Participants diagnosed with intellectual disability and an IQ score below 70.
- Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:
See the full eligibility criteria
- Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the...
- Participants with an AISRS total score meeting the following criteria:
- Not receiving medication treatment for ADHD: 28 points or higher
- Receiving medication treatment for ADHD: 22 points or higher
- Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.
- Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound how well it works or safety assessments. Examples...
- Participants diagnosed with a personality disorder according to DSM-5 criteria.
- Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.
- Participants diagnosed with intellectual disability and an IQ score below 70.
- Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:
- Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a ""yes"" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline/Screening version at...
- Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria.
- Participants diagnosed with eating disorders and feeding disorders according to DSM-5 diagnostic criteria.
- Participants who show a positive reaction in alcohol tests or urine drug tests at screening.
- Participants with complications or a history of the following neurological disorders:
- Epilepsy
- Seizures (other than infantile febrile seizures)
- Syncope
- Tourette's disorder
- History of significant head trauma with clinically significant loss of consciousness
- Dementia
- Cerebrovascular disease
- Parkinson's disease
- Intracranial lesions
- Other severe neurological disorders
- Participants with complications or a history of cardiovascular diseases.
- Participants with clinical laboratory test results at screening that meet any of the following criteria:
- Platelets \<= 75,000/mm3
- Hemoglobin \<= 9 g/dL
- Neutrophils, absolute \<= 1000/mm3
- AST \> 2 x ULN
- ALT \> 2 x ULN
- Creatinine \>= 2 mg/dL
- 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)...
- 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
- 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 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, 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.