A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT03605849|
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder Attention Deficit Hyperactivity Disorder||Drug: Centanafadine SR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, 52-Week, Multicenter Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder|
|Actual Study Start Date :||February 14, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
400 mg total daily dose
Drug: Centanafadine SR
200 mg, BID, oral tablets
Other Name: EB-1020
- Adverse Event (AE) Reporting [ Time Frame: Up to 52 weeks or early termination ]Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine safety and tolerability of centanafadine SR tablets
- Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Up to 52 weeks or early termination ]18-item scale with a total score range of 0 to 54 points. Composed of 2 subscales that can range from 0 to 27 points. A higher value represents a worse outcome. Efficacy endpoint. Results will be assessed to determine effectiveness of drug.
- Clinical Global Impression-Severity of Illness Scale (CGI-S) [ Time Frame: Up to 52 weeks or early termination ]An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome.Efficacy endpoint. Results will be assessed to determine effectiveness of drug.
- ADHD Impact Module - Adult (AIM-A) [ Time Frame: Up to 52 weeks or early termination ]Scale composed of 3 subscales with a maximum score of 100. A lower score indicates a worse outcome. Exploratory endpoint; comparison of baseline score to other points throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605849
|Contact: Otsuka Call Center||844-687-8522||OtsukaRMReconciliation@rmpdc.org|
|United States, California|
|For additional information regarding sites, contact 844-687-8522||Recruiting|
|Culver City, California, United States, 90230|