Trial · NCT03176771
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
NCT03176771, Phase 2, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia. Trials, record NCT03176771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03176771
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
- NCT number
- NCT03176771
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Tardive Dyskinesia
- Interventions
- MT-5199, Placebo
- First posted
- 2017-06-05
- Last updated
- 2026-01-07
- Results first posted
- 2023-08-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 | Baseline and Week 6 | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
| Secondary | Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) | Week 6 | Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline) |
| Secondary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 | Baseline and Week 6 | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
| Secondary | Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6 | Week 6 | Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). |
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 | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 | Baseline and Week 6 | The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:~* Subjects in the ITT analysis set~* Subjects for whom the Week 6 AIMS total score (central assessment) is available | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) | Week 6 | The analysis population (78 in the placebo, 67 in the MT-5199 40 mg, and 53 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:~* Subjects in the ITT analysis set~* Subjects for whom the Week 6 AIMS total score (central assessment) is available and the baseline AIMS total score (central assessment) is not zero | percentage of AIMS responders | NUMBER |
| SECONDARY | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 | Baseline and Week 6 | The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:~* Subjects in the ITT analysis set~* Subjects for whom the Week 6 AIMS total score (site assessment) is available | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6 | Week 6 | The analysis population (80 in the placebo, 70 in the MT-5199 40 mg, and 60 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:~* Subjects in the ITT analysis set~* Subjects for whom the Week 6 CGI-TD score is available | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
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 Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 | Placebo (Double-Blind Placebo-Controlled Period) | -0.1 | 95% Confidence Interval -0.8 to 0.5 | units on a scale | |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | -2.3 | 95% Confidence Interval -3.0 to -1.7 | units on a scale | |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | -3.7 | 95% Confidence Interval -4.4 to -3.0 | units on a scale | |
| Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) | Placebo (Double-Blind Placebo-Controlled Period) | 10.3 | percentage of AIMS responders | ||
| Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 23.9 | percentage of AIMS responders | ||
| Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 47.2 | percentage of AIMS responders | ||
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 | Placebo (Double-Blind Placebo-Controlled Period) | -2.3 | 95% Confidence Interval -3.2 to -1.5 | units on a scale | |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | -3.8 | 95% Confidence Interval -4.7 to -3.0 | units on a scale | |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6 | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | -4.7 | 95% Confidence Interval -5.6 to -3.8 | units on a scale | |
| Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6 | Placebo (Double-Blind Placebo-Controlled Period) | 3.4 | 95% Confidence Interval 3.2 to 3.6 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Placebo-Controlled Period | STARTED | Placebo (Double-Blind Placebo-Controlled Period) | 85 | |
| Double-Blind Placebo-Controlled Period | STARTED | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 86 | |
| Double-Blind Placebo-Controlled Period | STARTED | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 85 | |
| Double-Blind Placebo-Controlled Period | STARTED | MT-5199 40 mg (Double-Blind Extension Period) | 0 | |
| Double-Blind Placebo-Controlled Period | STARTED | MT-5199 80 mg (Double-Blind Extension Period) | 0 | |
| Double-Blind Placebo-Controlled Period | COMPLETED | Placebo (Double-Blind Placebo-Controlled Period) | 80 | |
| Double-Blind Placebo-Controlled Period | COMPLETED | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 71 | |
| Double-Blind Placebo-Controlled Period | COMPLETED | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 60 | |
| Double-Blind Placebo-Controlled Period | COMPLETED | MT-5199 40 mg (Double-Blind Extension Period) | 0 | |
| Double-Blind Placebo-Controlled Period | COMPLETED | MT-5199 80 mg (Double-Blind Extension Period) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events255
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 | Placebo (Double-Blind Placebo-Controlled Period) | 1 | 84 | |
| other | Constipation | Gastrointestinal disorders | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 2 | 85 | |
| other | Constipation | Gastrointestinal disorders | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 1 | 84 | |
| other | Constipation | Gastrointestinal disorders | MT-5199 40 mg (Double-Blind Extension Period) | 7 | 108 | |
| other | Constipation | Gastrointestinal disorders | MT-5199 80 mg (Double-Blind Extension Period) | 8 | 95 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | Placebo (Double-Blind Placebo-Controlled Period) | 1 | 84 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 3 | 85 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 9 | 84 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | MT-5199 40 mg (Double-Blind Extension Period) | 7 | 108 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | MT-5199 80 mg (Double-Blind Extension Period) | 12 | 95 |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Double-Blind Placebo-Controlled Period) | 0 | 84 |
| Total, all-cause mortality | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 0 | 85 |
| Total, all-cause mortality | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 0 | 84 |
| Total, all-cause mortality | MT-5199 40 mg (Double-Blind Extension Period) | 3 | 108 |
| Total, all-cause mortality | MT-5199 80 mg (Double-Blind Extension Period) | 4 | 95 |
| Total, other adverse events | Placebo (Double-Blind Placebo-Controlled Period) | 15 | 84 |
| Total, other adverse events | MT-5199 40 mg (Double-Blind Placebo-Controlled Period) | 30 | 85 |
| Total, other adverse events | MT-5199 80 mg (Double-Blind Placebo-Controlled Period) | 44 | 84 |
| Total, other adverse events | MT-5199 40 mg (Double-Blind Extension Period) | 71 | 108 |
| Total, other adverse events | MT-5199 80 mg (Double-Blind Extension Period) | 69 | 95 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03176771
GET https://conductscience.org/api/trials/v1/NCT03176771/flow?page=2