Trial · NCT03605849

A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder

NCT03605849, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2024-10-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. Trials, record NCT03605849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03605849

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder
NCT number: NCT03605849
Status: Completed
Phases: Phase 3
Enrollment: 662 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
Interventions: Centanafadine SR
First posted: 2018-07-30
Last updated: 2024-10-01
Results first posted: 2024-10-01

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	From first dose of study drug up to 30 days after last dose of study drug (Up to approximately Week 56)	An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy. TEAEs were graded on a 3-point scale and the intensity of an adverse experience was defined as follows: 1 = Mild: Discomfort noticed, but no disruption to daily activity, 2 = Moderate: Discomfort sufficient to reduce or affect normal daily activity, and 3 = Severe: Inability to work or perform normal daily activity.
Other	Adult ADHD Investigator Symptom Rating Scale (AISRS)	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.
Other	Clinical Global Impression-Severity of Illness Scale (CGI-S)	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.
Other	ADHD Impact Module - Adult (AIM-A)	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	From first dose of study drug up to 30 days after last dose of study drug (Up to approximately Week 56)	Safety Sample comprised all participants who received at least 1 dose of IMP. As prespecified in the SAP, data was analyzed based on the treatments (centanafadine SR 200mg, 400 mg or placebo) received by the participants in the parent double-blind phase 3 trials (405-201-00013 or 405-201-00014), and the centanafadine SR 400 mg received by de novo participants during this current study. Data from 2 parent studies was analyzed and reported in a combined way for rollover participants.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Adult ADHD Investigator Symptom Rating Scale (AISRS)	Up to 52 weeks or early termination
OTHER_PRE_SPECIFIED	Clinical Global Impression-Severity of Illness Scale (CGI-S)	Up to 52 weeks or early termination
OTHER_PRE_SPECIFIED	ADHD Impact Module - Adult (AIM-A)	Up to 52 weeks or early termination

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 200 mg	Participants With TEAEs	98	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 400 mg	Participants With TEAEs	89	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Placebo	Participants With TEAEs	123	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	De Novo Centanafadine SR 400 mg	Participants With TEAEs	91	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 200 mg	Participants With Mild TEAE	73	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 400 mg	Participants With Mild TEAE	59	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Placebo	Participants With Mild TEAE	92	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	De Novo Centanafadine SR 400 mg	Participants With Mild TEAE	70	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 200 mg	Participants With Moderate TEAE	58	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded by Severity	Prior Centanafadine SR 400 mg	Participants With Moderate TEAE	53	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prior Centanafadine SR 200 mg	156
Overall Study	STARTED	Prior Centanafadine SR 400 mg	151
Overall Study	STARTED	Prior Placebo	187
Overall Study	STARTED	De Novo Centanafadine SR 400 mg	168
Overall Study	Safety Sample	Prior Centanafadine SR 200 mg	154
Overall Study	Safety Sample	Prior Centanafadine SR 400 mg	149
Overall Study	Safety Sample	Prior Placebo	184
Overall Study	Safety Sample	De Novo Centanafadine SR 400 mg	166
Overall Study	COMPLETED	Prior Centanafadine SR 200 mg	78
Overall Study	COMPLETED	Prior Centanafadine SR 400 mg	72

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Prior Centanafadine SR 200 mg	11	154
other	Diarrhoea	Gastrointestinal disorders	Prior Centanafadine SR 400 mg	6	149
other	Diarrhoea	Gastrointestinal disorders	Prior Placebo	13	184
other	Diarrhoea	Gastrointestinal disorders	De Novo Centanafadine SR 400 mg	16	166
other	Dry Mouth	Gastrointestinal disorders	Prior Centanafadine SR 200 mg	7	154
other	Dry Mouth	Gastrointestinal disorders	Prior Centanafadine SR 400 mg	6	149
other	Dry Mouth	Gastrointestinal disorders	Prior Placebo	12	184
other	Dry Mouth	Gastrointestinal disorders	De Novo Centanafadine SR 400 mg	3	166
other	Nausea	Gastrointestinal disorders	Prior Centanafadine SR 200 mg	11	154
other	Nausea	Gastrointestinal disorders	Prior Centanafadine SR 400 mg	7	149

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prior Centanafadine SR 200 mg	0	154
Total, all-cause mortality	Prior Centanafadine SR 400 mg	0	149
Total, all-cause mortality	Prior Placebo	0	184
Total, all-cause mortality	De Novo Centanafadine SR 400 mg	0	166
Total, other adverse events	Prior Centanafadine SR 200 mg	59	154
Total, other adverse events	Prior Centanafadine SR 400 mg	49	149
Total, other adverse events	Prior Placebo	81	184
Total, other adverse events	De Novo Centanafadine SR 400 mg	61	166
Total, serious adverse events	Prior Centanafadine SR 200 mg	1	154
Total, serious adverse events	Prior Centanafadine SR 400 mg	1	149

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT03605849/events?page=2

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