Trial · NCT04200352
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Baseline up to Week 55 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | Baseline to Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants who provided a baseline value and at least one post-baseline value for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in ESRS Subscale II Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in CBCL Syndrome Total Score at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | 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) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | 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) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Scale Score (Global, Physician Rated) at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pediatric Evaluation Disability Inventory-Computer Adapted Test (PEDI-CAT) Score (Activities of Daily Living [ADL], Caregiver Completed, Content-Balanced Version) at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | 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 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | 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 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) Score (Physician Rated) at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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