Trial · NCT03605680
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
NCT03605680, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder. Trials, record NCT03605680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03605680
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
- NCT number
- NCT03605680
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- Interventions
- Centanafadine SR, Placebo, Centanafadine SR
- First posted
- 2018-07-30
- Last updated
- 2022-03-15
- Results first posted
- 2021-05-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Day 42 | The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) | Baseline and Day 42 | CGI-S is an observer-rated scale used to measure symptom severity with a total score range of 0 to 7 where 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A negative change from Baseline indicates improvement. MMRM was used for the analysis. |
| Other | Adverse Event Reporting | Up to 59 days | Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine safety and tolerability of centanafadine SR tablets. |
| Other | ADHD Impact Module - Adult (AIM-A) | Up to 42 days | 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. |
| Other | Adult ADHD Self Report Scale (ASRS) | Up to 42 days | An 18 question report, total score ranges from 0 to 124. A higher score denotes a worse outcome. Exploratory endpoint; comparison of baseline score to other points throughout the study. |
| Other | Adult ADHD Investigator Symptom Rating Scale (AISRS) | Up to 42 days | Change from baseline total score compared to every scheduled visit. Each subscale is composed of 9 items each. Scores can range from 0 to 27, with a higher score representing a worse outcome. Change from baseline scores are compared to every scheduled visit score. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Day 42 | Efficacy sample FAS included all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for AISRS total score in the Double-blind Treatment Period. Overall number analysed are the participants with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) | Baseline and Day 42 | Efficacy sample FAS included all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for AISRS total score in the Double-blind Treatment Period. Overall number analysed are the participants with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Adverse Event Reporting | Up to 59 days | |||
| OTHER_PRE_SPECIFIED | ADHD Impact Module - Adult (AIM-A) | Up to 42 days | |||
| OTHER_PRE_SPECIFIED | Adult ADHD Self Report Scale (ASRS) | Up to 42 days | |||
| OTHER_PRE_SPECIFIED | Adult ADHD Investigator Symptom Rating Scale (AISRS) | Up to 42 days |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) | Double-blind Treatment Period: Centanafadine SR 200 mg | -10.1 | Standard Error 0.99 | score on a scale | |
| Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) | Double-blind Treatment Period: Centanafadine SR 400 mg | -9.73 | Standard Error 0.98 | score on a scale | |
| Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) | Double-blind Treatment Period: Placebo | -6.98 | Standard Error 0.98 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) | Double-blind Treatment Period: Centanafadine SR 200 mg | -0.78 | Standard Error 0.09 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) | Double-blind Treatment Period: Centanafadine SR 400 mg | -0.79 | Standard Error 0.08 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) | Double-blind Treatment Period: Placebo | -0.52 | Standard Error 0.08 | score on a scale |
Source ClinicalTrials.gov
Participant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| SB Placebo Run-in Period (1 Week) | STARTED | Single-blind (SB) Run-in Period: Placebo | 604 | |
| SB Placebo Run-in Period (1 Week) | STARTED | Double-blind Treatment Period: Centanafadine SR 200 mg | 0 | |
| SB Placebo Run-in Period (1 Week) | STARTED | Double-blind Treatment Period: Centanafadine SR 400 mg | 0 | |
| SB Placebo Run-in Period (1 Week) | STARTED | Double-blind Treatment Period: Placebo | 0 | |
| SB Placebo Run-in Period (1 Week) | Treated | Single-blind (SB) Run-in Period: Placebo | 584 | |
| SB Placebo Run-in Period (1 Week) | Treated | Double-blind Treatment Period: Centanafadine SR 200 mg | 0 | |
| SB Placebo Run-in Period (1 Week) | Treated | Double-blind Treatment Period: Centanafadine SR 400 mg | 0 | |
| SB Placebo Run-in Period (1 Week) | Treated | Double-blind Treatment Period: Placebo | 0 | |
| SB Placebo Run-in Period (1 Week) | COMPLETED | Single-blind (SB) Run-in Period: Placebo | 466 | |
| SB Placebo Run-in Period (1 Week) | COMPLETED | Double-blind Treatment Period: Centanafadine SR 200 mg | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events28
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 | Events |
|---|---|---|---|---|---|---|
| other | Dry Mouth | Gastrointestinal disorders | Placebo: SB Run-in Period Only | 0 | 138 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo + Centanafadine SR 200 mg | 6 | 149 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo + Centanafadine SR 400 mg | 9 | 149 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo + Placebo | 0 | 148 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo: SB Run-in Period Only | 0 | 138 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + Centanafadine SR 200 mg | 8 | 149 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + Centanafadine SR 400 mg | 1 | 149 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + Placebo | 3 | 148 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo: SB Run-in Period Only | 0 | 138 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo + Centanafadine SR 200 mg | 9 | 149 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo: SB Run-in Period Only | 0 | 138 |
| Total, all-cause mortality | Placebo + Centanafadine SR 200 mg | 0 | 149 |
| Total, all-cause mortality | Placebo + Centanafadine SR 400 mg | 0 | 149 |
| Total, all-cause mortality | Placebo + Placebo | 0 | 148 |
| Total, other adverse events | Placebo: SB Run-in Period Only | 2 | 138 |
| Total, other adverse events | Placebo + Centanafadine SR 200 mg | 25 | 149 |
| Total, other adverse events | Placebo + Centanafadine SR 400 mg | 22 | 149 |
| Total, other adverse events | Placebo + Placebo | 18 | 148 |
| Total, serious adverse events | Placebo: SB Run-in Period Only | 0 | 138 |
| Total, serious adverse events | Placebo + Centanafadine SR 200 mg | 2 | 149 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03605680
GET https://conductscience.org/api/trials/v1/NCT03605680/flow?page=2