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Trial · NCT03813238

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15Baseline, Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the MD-CRS Part I Total Score (General Assessment, Centrally Read) at Week 15Baseline, Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleMEAN
SECONDARYCaregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleMEAN
SECONDARYClinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 15Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleMEAN
SECONDARYChange From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 15Baseline, Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleMEAN
SECONDARYChange From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Centrally Read) at Week 15Baseline, Week 15The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment.units on a scaleMEAN
SECONDARYChange From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in UHDRS-TMS Score (Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in UHDRS-TMC Score (Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in UHDRS-TMD Score (Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYChange 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 15Baseline, 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 scaleMEAN
SECONDARYChange From Baseline in the CP Module of the Pediatric Quality of Life Inventory (PedsQL) Total Score (Quality of Life [QoL], Participant/Caregiver) at Week 15Baseline, 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. 'Number analyzed' = participants evaluable for specified category.
units on a scaleMEAN
SECONDARYPatient Global Impression of Improvement (PGI-I) Scale Score (Global, Participant/Caregiver) at Week 15Week 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 scaleMEAN
SECONDARYChange From Baseline in Clinical Global Impression of Severity (CGI-S) Scale Score (Global, Physician Rated) at Week 15Baseline, 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 scaleMEAN
SECONDARYNumber of Participants With CaGI-I ResponseWeek 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With CGI-I ResponseWeek 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With CGI-S ResponseWeek 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.
ParticipantsCOUNT_OF_PARTICIPANTS

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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