A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
NCT ID: NCT03605836
Last Updated: 2021-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
590 participants
INTERVENTIONAL
2019-01-16
2020-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single-blind Run-in Period: Placebo
Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1).
Placebo
BID, oral tablet
Double-blind Treatment Period: Centanafadine SR 200 mg
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Centanafadine SR
100 mg, BID, oral tablets
Double-blind Treatment Period: Centanafadine SR 400 mg
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 400 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Centanafadine SR
200 mg, BID, oral tablets
Double-blind Treatment Period: Placebo
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Placebo
BID, oral tablet
Interventions
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Centanafadine SR
100 mg, BID, oral tablets
Placebo
BID, oral tablet
Centanafadine SR
200 mg, BID, oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who were not receiving any pharmacological treatment for ADHD must have an Adult ADHD Investigator Symptom Rating Scale (AISRS) score of ≥ 28 at screening and baseline. Participants who were receiving pharmacological treatment for ADHD at screening must have a minimum AISRS score of ≥ 22 at screening, and a score of ≥ 28 at baseline.
* All participants must be willing to discontinue all prohibited psychotropic medications starting from the time of signing the informed consent through the 7-day follow-up period. Participants that do not rollover into Trial 405-201-00015 must be willing to discontinue all prohibited psychotropic medications starting from the time of signing the informed consent until after the follow-up telephone call 10 days after the last dose of IMP.
* Participants must have a Clinical Global Impression-Severity of Illness Scale (CGI-S) score of ≥ 4 (≥ moderate impairment) at baseline.
Exclusion Criteria
* Participant has a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.
* In the opinion of the investigator, participants has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate) given with an acceptable dose and duration of adulthood (aged 18 or older). NOTE: If participants has not derived significant therapeutic benefit due to an inability to tolerate side effects, eligibility can be discussed on case-by-case basis with the medical monitor.
* Participants who have a positive alcohol test (via breathalyzer or blood), a positive drug screen assessed prior to the baseline visit for cocaine, other illicit drugs (including marijuana), or prescription or OTC ADHD medications will be early terminated. This includes medications such as opioids or benzodiazepines taken without prescription.
* In the opinion of the investigator, the participants is unable to adhere to the treatment regimen or other requirements outlined in the protocol.
18 Years
55 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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For additional information regarding sites, contact 844-687-8522
Orlando, Florida, United States
Countries
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References
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Schein J, Cloutier M, Gauthier-Loiselle M, Catillon M, Xu C, Chan D, Childress A. Assessment of centanafadine in adults with attention-deficit/hyperactivity disorder: A matching-adjusted indirect comparison vs lisdexamfetamine dimesylate, atomoxetine hydrochloride, and viloxazine extended-release. J Manag Care Spec Pharm. 2024 Jun;30(6):528-540. doi: 10.18553/jmcp.2024.30.6.528.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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405-201-00014
Identifier Type: -
Identifier Source: org_study_id