Trial · NCT03813238
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
NCT03813238, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2023-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents. Trials, record NCT03813238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03813238
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
- NCT number
- NCT03813238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Cerebral Palsy, Dyskinetic
- Interventions
- TEV-50717, Placebo
- First posted
- 2019-01-23
- Last updated
- 2023-09-08
- Other registries' IDs
- eudract:2018-003742-17
- Results first posted
- 2023-09-08
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15 | Baseline, Week 15 | MD-CRS part II evaluates the severity of movement disorder in a scale of 0 to 4 in 7 body regions, all areas in which dyskinesia can be seen. All items were scored by the rater in the clinic and were centrally read based on video recording. In rating the movement disorder of body part, 0 refers to absence of a movement disorder and 4 refers to a situation where movement disorder is present during all of the tasks for the region examined and/or involves 3 or more of the other regions, making completion impossible. The 7 body regions are (i) eye and periorbital region, (ii) face, (iii) tongue and perioral region, (iv) neck, (v) trunk, (vi) upper limb, and (vii) lower limb. Total score was obtained by summing the individual items scores and ranges from 0 (absent of a movement disorder) to 28 (marked/prolonged movement disorder), with higher scores indicating more movement disorder. Least square (LS) mean and standard error (SE) was calculated using a mixed-model repeated-measures (MMRM). |
| Secondary | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Centrally Read) at Week 15 | Baseline, Week 15 | The MD-CRS part I evaluates the impact of dyskinesia in cerebral palsy (DCP) on the activities of the participant and provides a general assessment of the movement disorder of motor function (7 items), oral/verbal function (3 items), self-care (3 items), and attention/alertness (2 items) on a scale of 0 (present) to 4 (absent). All items were scored by the rater in the clinic and were centrally read based on video recording. The total score was obtained by summing the individual items scores and ranges from 0 (marked/prolonged disorder) to 60 (absent of a disorder), with higher scores indicating lesser disorder. |
| Secondary | Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15 | Week 15 | The CaGI-I is single item questionnaire to assess the caregiver's impression of improvement in dyskinesia symptoms after initiating therapy. The scale is a caregiver-reported outcome that aims to evaluate all aspects of participants' health and determine if there has been an overall improvement or not in dyskinesia symptoms. The caregiver selected the 1 response from the response options that gave the most accurate description of change in dyskinesia symptoms of the participant they cared for from the beginning of the study: 1=very much improved (since the initiation of treatment); 2=much improved; 3=minimally improved; 4=no change from baseline (symptoms remain essentially unchanged); 5=minimally worse; 6=much worse; 7=very much worse (since the initiation of treatment). |
| Secondary | Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 15 | Week 15 | CGI-I is a clinician-reported outcome that uses a 7-point Likert scale that allows the clinician to compare participant's condition at the visit to the baseline condition as follows: 1=very much improved since initiation of treatment (nearly all better; good level of functioning; minimal symptoms; represents a very substantial change); 2=much improved (notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain); 3=minimally improved (slightly better with little or no clinically meaningful reduction of symptoms; represents very little change in basic clinical status, level of care, or functional capacity); 4=no change from baseline (symptoms remain unchanged); 5=minimally worse (slightly worse but may not be clinically meaningful); 6=much worse (clinically significant increase in symptoms and diminished functioning); 7=very much worse since the initiation of treatment (severe exacerbation of symptoms and loss of functioning). |
| Secondary | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 15 | Baseline, Week 15 | The UHDRS-TMC is part of the Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) assessment and assesses the severity of chorea in the 7 body parts: face, mouth, trunk, and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). The central rating was done for all participants, based on the videos collected for the central rating of MD-CRS. The TMC score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 28 (marked/prolonged), with higher scores indicating the worse symptoms. |
| Secondary | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Centrally Read) at Week 15 | Baseline, Week 15 | The UHDRS-TMD is part of the UHDRS-TMS assessment and assesses the severity of dystonia in the 5 body parts: trunk and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). The central rating was done for all participants, based on the videos collected for the central rating of MD-CRS. The TMD score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 20 (marked/prolonged), with higher scores indicating the worse symptoms. |
| Secondary | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) at Week 15 | Baseline, Week 15 | The MD-CRS part I evaluates the impact of DCP on the activities of the participant and provides a general assessment of the movement disorder of motor function (7 items), oral/verbal function (3 items), self-care (3 items), and attention/alertness (2 items) on a scale of 0 (present) to 4 (absent). All items were scored by the investigational center physician. The total score was obtained by summing the individual items scores and ranges from 0 (marked/prolonged movement disorder) to 60 (absent of a movement disorder), with higher scores indicating lesser movement disorder. |
| Secondary | Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) at Week 15 | Baseline, Week 15 | The MD-CRS part II evaluates the severity of the movement disorder in a scale of 0 to 4 in 7 body regions, all areas in which dyskinesia can be seen in participants with CP. All items were scored by the investigational center physician. In rating the movement disorder of the body part, 0 refers to absence of a movement disorder and 4 refers to a situation where movement disorder is present during all of the tasks for the region examined and/or involves 3 or more of the other regions, making completion impossible. The 7 body regions are (i) eye and periorbital region, (ii) face, (iii) tongue and perioral region, (iv) neck, (v) trunk, (vi) upper limb, and (vii) lower limb. The total score was obtained by summing the individual items scores and ranges from 0 (absent of a movement disorder) to 28 (marked/prolonged movement disorder), with higher scores indicating more movement disorder. |
| Secondary | Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated) at Week 15 | Baseline, Week 15 | The MD-CRS Global Index is a global measure of the MD-CRS that consolidates the information from parts I and II using the method of weighted means of the 2 normalized indexes obtained from each part. The standardized/normalized score for each item of MD-CRS parts I and II with value X is calculated using the formula: Xst = X - Xmin divided by Xmax - Xmin, where Xmax is the maximum value for the score, and Xmin is the minimum value for the score, or 4 and 0 respectively. The normalized index for the scale, MD-CRS parts I or II, Index I or II, is calculated as the mean value of Xst. The MD-CRS Global Index is the weighted mean of the normalized indexes for centrally read MD-CRS parts I and II using the formula: Global index = n1 \* index 1 + n2 \* index 2 divided by n1 + n2, where n1 and n2 are the numbers of items in MD-CRS parts I and II respectively. The minimum score is 0 (better) and the maximum score is 1 (worse). The higher score indicates more severe movement disorder. |
| Secondary | Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read) at Week 15 | Baseline, Week 15 | The MD-CRS Global Index is a global measure of the MD-CRS that consolidates the information from parts I and II using the method of weighted means of the 2 normalized indexes obtained from each part. The standardized/normalized score for each item of MD-CRS parts I and II with value X is calculated using the formula: Xst = X - Xmin divided by Xmax - Xmin, where Xmax is the maximum value for the score, and Xmin is the minimum value for the score, or 4 and 0 respectively. The normalized index for the scale, MD-CRS parts I or II, Index I or II, is calculated as the mean value of Xst. The MD-CRS Global Index is the weighted mean of the normalized indexes for centrally read MD-CRS parts I and II using the formula: Global index = n1 \* index 1 + n2 \* index 2 divided by n1 + n2, where n1 and n2 are the numbers of items in MD-CRS parts I and II respectively. The minimum score is 0 (better) and the maximum score is 1 (worse). The higher score indicates more severe movement disorder. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
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 the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Centrally Read) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | MEAN |
| SECONDARY | Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15 | Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 15 | Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Centrally Read) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read) at Week 15 | Baseline, Week 15 | The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | units on a scale | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group88
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 the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15 | Placebo | -0.4 | Standard Error 1.09 | units on a scale | |
| Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15 | TEV-50717 | -1.5 | Standard Error 0.88 | units on a scale | |
| Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Centrally Read) at Week 15 | Placebo | -0.8 | Standard Deviation 2.51 | units on a scale | |
| Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Centrally Read) at Week 15 | TEV-50717 | -0.7 | Standard Deviation 2.10 | units on a scale | |
| Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15 | Placebo | 3.3 | Standard Deviation 0.83 | units on a scale | |
| Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15 | TEV-50717 | 3.3 | Standard Deviation 0.84 | units on a scale | |
| Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 15 | Placebo | 3.5 | Standard Deviation 0.87 | units on a scale | |
| Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 15 | TEV-50717 | 3.4 | Standard Deviation 0.78 | units on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 15 | Placebo | 0.3 | Standard Deviation 2.87 | units on a scale | |
| Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 15 | TEV-50717 | -1.2 | Standard Deviation 2.52 | units on a scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | STARTED | TEV-50717 | 41 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 22 | |
| Overall Study | Received at Least 1 Dose of Study Drug | TEV-50717 | 40 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | Placebo | 21 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | TEV-50717 | 40 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | COMPLETED | TEV-50717 | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | TEV-50717 | 11 |
Source ClinicalTrials.gov
Adverse events44
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 | 2 | 22 | 2 |
| other | Constipation | Gastrointestinal disorders | TEV-50717 | 1 | 40 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | TEV-50717 | 3 | 40 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 22 | 1 |
| other | Nausea | Gastrointestinal disorders | TEV-50717 | 3 | 40 | 3 |
| other | Salivary hypersecretion | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Salivary hypersecretion | Gastrointestinal disorders | TEV-50717 | 2 | 40 | 2 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Vomiting | Gastrointestinal disorders | TEV-50717 | 5 | 40 | 6 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, all-cause mortality | TEV-50717 | 0 | 40 |
| Total, other adverse events | Placebo | 10 | 22 |
| Total, other adverse events | TEV-50717 | 34 | 40 |
| Total, serious adverse events | Placebo | 0 | 22 |
| Total, serious adverse events | TEV-50717 | 0 | 40 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TEV-50717 vs Placebo: Number of Participants With PGI-I Response | Trial comparisons |
| TEV-50717 vs Placebo: Number of Participants With CaGI-I Response | Trial comparisons |
| TEV-50717 vs Placebo: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| TEV-50717 vs Placebo: Number of Participants With CGI-I Response | Trial comparisons |
| TEV-50717 vs Placebo: deaths from any cause | Trial comparisons |
| TEV-50717 vs Placebo: Number of Participants With CGI-S Response | Trial comparisons |
| TEV-50717 vs Placebo: serious adverse events | Trial comparisons |
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/NCT03813238
GET https://conductscience.org/api/trials/v1/NCT03813238/registered?page=2