Trial · NCT05113953
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
NCT05113953, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder. Trials, record NCT05113953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05113953
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
- NCT number
- NCT05113953
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 147 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Binge-Eating Disorder
- Interventions
- Centanafadine, Placebo
- First posted
- 2021-11-09
- Last updated
- 2025-09-09
- Results first posted
- 2025-09-09
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Number of Binge Eating Days Per Week | Baseline, Weeks 7 to 8 | Binge eating day was defined as a day with at least one binge eating episode. Least squares (LS) mean was determined by Mixed-effect Model Repeated Measures (MMRM) method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, and an interaction term of treatment by visit week. |
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Baseline, Week 8 | The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity on scale with a score range of 0 to 7 where, 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates. |
| Secondary | Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs) | From first dose of study drug up to 1 week post last dose (Up to 9 weeks) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. AESIs were newly acquired skin eruptions that were non-traumatic which included eruptions such as skin rashes, skin irritations, skin reactions, or acneiform lesions. AEs related to abuse included: Feeling abnormal (floaty feeling in the head), euphoric mood (feeling high). MHIs included: IMP accounting errors, not involving suspected abuse nor diversion by participant; Non-compliance with trial procedures, not involving suspected abuse nor diversion by participant; and other cases involving neither suspected abuse nor diversion of trial IMP by participant. |
| Secondary | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities | From first dose of study drug up to 1 week post last dose (Up to 9 weeks) | Laboratory assessments included hematology, serum chemistry, and urinalysis. Abnormality criteria included: In milligrams per deciliter (mg/dL) \[high bilirubin ≥2.0, low/high calcium ≤8.2/ ≥12, high cholesterol fasting ≥240, high glucose, fasting ≥100, high triglycerides, fasting ≥150, high urate ≥8.5 female / ≥10.5 male, high protein urine ≥2 units increase\]; high creatine kinase (units per liter \[U/L\]) \>3xupper limit of normal (ULN); high eosinophils/leukocytes ≥10%, low neutrophils/leukocytes ≤15%; In 10\^3/microliter (µL) \[low or high leukocytes ≤2.8x10\^9/L or ≥16.0x10\^9/L, low neutrophils ≤1.5x10\^9/L\]. The categories with at least one participant with clinically relevant value are reported here. |
| Secondary | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities | From first dose of study drug up to 1 week post last dose (Up to 9 weeks) | Vital sign measurements included heart rate in supine and standing positions (low: \<50 beats per minute \[bpm\] and decrease ≥10 bpm; High: \>100 bpm and increase ≥10 bpm), systolic blood pressure (BP) in supine and standing positions (low: \<90 millimeters of mercury \[mmHg\] and decrease ≥20 mmHg; High: ≥140 mmHg and increase ≥20 mmHg), diastolic BP in supine and standing positions (low: \<60 mmHg and decrease ≥10 mmHg; High: ≥90 mmHg and increase ≥10 mmHg), weight in kilograms (kg) (low: ≥7% decrease; High: ≥7% increase), orthostatic hypotension, (≥30mmHg decrease is systolic BP or ≥20 mmHg in diastolic BP after at least 3 minutes of standing compared to the previous supine BP), and orthostatic tachycardia (≥25 bpm increase in heart rate from supine to standing). The categories with at least one participant with clinically relevant value are reported here. |
| Secondary | Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Abnormalities | From first dose of study drug up to 1 week post last dose (Up to 9 weeks) | 12-lead ECG abnormality criteria included Rhythm: Supraventricular premature beat (not present at baseline and present post baseline); and Conduction: Primary (1°) atrioventricular block (PR ≥200 milliseconds \[msec\] and increase of ≥50 msec). |
| Secondary | Study Medication Withdrawal Questionnaire (SMWQ) Total Mean Score | Week 8 | SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with IMP. The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which in which the terms "amphetamines and methamphetamine" are replaced with the term "the study medication." This change was intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. This questionnaire comprises of 13 items which describe symptoms associated with the cessation of study medication use for which participants indicate severity on a scale with scores ranging from 0 (no withdrawal symptoms) to 4 (most severe withdrawal symptom). The total score is calculated as the sum of all the scores for the 13 items, ranging from 0 to 52. Lower scores indicate less withdrawal symptoms. |
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline, Week 8 | The HAM-A scale assesses both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It consists of 14 items to rate the severity of symptoms of anxiety, each scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Total score was calculated as the sum of the 14 individual item scores, ranging from 0 to 56 and categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and \>=31: severe. A higher score indicates a more severe anxiety. |
| Secondary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline, Week 8 | The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. The questionnaire includes questions on ten symptoms: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each question is scored on a range of 0 to 6 points and the total score was calculated as the sum of the 10 individual item scores, ranging from 0 to 60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher scores indicate increased depressive symptoms. |
| Secondary | Number of Participants With Suicidality as Measured by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Week 8 | The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation (SI) and suicidal behavior rating scale. It rates an individual's degree of SI on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide. Suicidality was reported in this outcome measure, defined as at least 1 occurrence of suicidal ideation or at least 1 occurrence of suicidal behavior for each assessment period. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Number of Binge Eating Days Per Week | Baseline, Weeks 7 to 8 | Efficacy analysis set included all the randomized participants who received at least 1 dose of IMP and had a baseline value and at least 1 valid post-randomization efficacy evaluation within the double-blind treatment period. | binge eating days per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Baseline, Week 8 | Efficacy analysis set included all the randomized participants who received at least 1 dose of IMP and had a baseline value and at least 1 valid post-randomization efficacy evaluation within the double-blind treatment period. 'Overall number of participants analyzed' is the number of participants with data available for outcome measure analysis. 'Number analyzed' is the number of participants with data available for analysis at the specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Baseline, Weeks 1, 2, 3, 4, and 6 | |||
| OTHER_PRE_SPECIFIED | Mean Clinical Global Impression - Change (CGI-C) Score | Week 8 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score | Baseline, Week 8 | |||
| OTHER_PRE_SPECIFIED | Percentage of Participants With Four-Week Cessation From Binging | Week 8 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in Number of Binge Episodes Per Week | Baseline, Weeks 7 to 8 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in Patient Global Impression - Severity (PGI-S) Score | Baseline, Week 8 | |||
| OTHER_PRE_SPECIFIED | Mean Patient Global Impression - Change (PGI-C) Score | Week 8 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores | Baseline, Week 8 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group114
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 Number of Binge Eating Days Per Week | Centanafadine 400 mg | -3.44 | Standard Error 0.23 | binge eating days per week | |
| Change From Baseline in Number of Binge Eating Days Per Week | Centanafadine 200 mg | -3.07 | Standard Error 0.23 | binge eating days per week | |
| Change From Baseline in Number of Binge Eating Days Per Week | Placebo | -3.01 | Standard Error 0.23 | binge eating days per week | |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Centanafadine 400 mg | -2.15 | Standard Error 0.18 | score on a scale | |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Centanafadine 200 mg | -1.43 | Standard Error 0.18 | score on a scale | |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score | Placebo | -1.61 | Standard Error 0.18 | score on a scale | |
| Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs) | Centanafadine 400 mg | AEs | 34 | Participants | |
| Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs) | Centanafadine 200 mg | AEs | 28 | Participants | |
| Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs) | Placebo | AEs | 24 | Participants | |
| Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Related to Rash, AEs Related to Abuse, and AEs Involving Medication Handling Irregularities (MHIs) | Centanafadine 400 mg | AESIs Related to Rash | 5 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Centanafadine 400 mg | 49 | |
| Overall Study | STARTED | Centanafadine 200 mg | 49 | |
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | Safety Analysis Set | Centanafadine 400 mg | 49 | |
| Overall Study | Safety Analysis Set | Centanafadine 200 mg | 49 | |
| Overall Study | Safety Analysis Set | Placebo | 49 | |
| Overall Study | Efficacy Analysis Set | Centanafadine 400 mg | 49 | |
| Overall Study | Efficacy Analysis Set | Centanafadine 200 mg | 48 | |
| Overall Study | Efficacy Analysis Set | Placebo | 47 | |
| Overall Study | COMPLETED | Centanafadine 400 mg | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events21
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 | Constipation | Gastrointestinal disorders | Centanafadine 400 mg | 3 | 49 | |
| other | Constipation | Gastrointestinal disorders | Centanafadine 200 mg | 2 | 49 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 49 | |
| other | Diarrhoea | Gastrointestinal disorders | Centanafadine 400 mg | 5 | 49 | |
| other | Diarrhoea | Gastrointestinal disorders | Centanafadine 200 mg | 3 | 49 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 49 | |
| other | Dry Mouth | Gastrointestinal disorders | Centanafadine 400 mg | 4 | 49 | |
| other | Dry Mouth | Gastrointestinal disorders | Centanafadine 200 mg | 2 | 49 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 1 | 49 | |
| other | Nausea | Gastrointestinal disorders | Centanafadine 400 mg | 5 | 49 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Centanafadine 400 mg | 0 | 49 |
| Total, all-cause mortality | Centanafadine 200 mg | 0 | 49 |
| Total, all-cause mortality | Placebo | 0 | 49 |
| Total, other adverse events | Centanafadine 400 mg | 20 | 49 |
| Total, other adverse events | Centanafadine 200 mg | 12 | 49 |
| Total, other adverse events | Placebo | 11 | 49 |
| Total, serious adverse events | Centanafadine 400 mg | 0 | 49 |
| Total, serious adverse events | Centanafadine 200 mg | 0 | 49 |
| Total, serious adverse events | Placebo | 0 | 49 |
Source ClinicalTrials.gov
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.
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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