A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

Conditions

Dyskinesia due to cerebral palsy (DCP)

Brief summary

The change in the Total Maximal Chorea (TMC) score of the Unified Huntington Disease Rating Scale (UHDRS) from baseline to the average of the Week 12 and Week 14 assessments

Detailed description

The change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 14, The change in Movement Disorders - Childhood Rating Scale (MD-CRS) Part I score from baseline to the average of the Week 12 and Week 14 assessments, The change in the Total Maximal Dystonia (TMD) score of the UHDRS from baseline to the average of the Week 12 and Week 14 assessment, Patient Global Impression of Improvement (PGI-I) score at Week 14 [ Time Frame: Week 14 ], Caregiver Global Impression of Improvement (CaGI-I) score at Week 14 [ Time Frame: Week 14 ], Clinical Global Impression of Improvement (CGI-I) score at Week 14 [ Time Frame: Week 14 ], Goal attainment score at Week 14 using the Goal Attainment Scale (GAS) [ Time Frame: Week 14 ], Change in pain assessment from baseline to Week 14 using the Faces Pain Scale-Revised (FPS-R) [ Time Frame: Baseline, Week 14 ], Change in the UHDRS Total Motor Score (TMS) from baseline to the average of the Week 12 and Week 14 assessments [ Time Frame: Baseline, Week 12 and Week 14 ]

Related papers

No related papers found yet.

Interventions

DRUGValbenazine

DRUGMatching placebo for valbenazine

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in the Total Maximal Chorea (TMC) score of the Unified Huntington Disease Rating Scale (UHDRS) from baseline to the average of the Week 12 and Week 14 assessments	—

Secondary

Measure	Time frame
The change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 14, The change in Movement Disorders - Childhood Rating Scale (MD-CRS) Part I score from baseline to the average of the Week 12 and Week 14 assessments, The change in the Total Maximal Dystonia (TMD) score of the UHDRS from baseline to the average of the Week 12 and Week 14 assessment, Patient Global Impression of Improvement (PGI-I) score at Week 14 [ Time Frame: Week 14 ], Caregiver Global Impression of Improvement (CaGI-I) score at Week 14 [ Time Frame: Week 14 ], Clinical Global Impression of Improvement (CGI-I) score at Week 14 [ Time Frame: Week 14 ], Goal attainment score at Week 14 using the Goal Attainment Scale (GAS) [ Time Frame: Week 14 ], Change in pain assessment from baseline to Week 14 using the Faces Pain Scale-Revised (FPS-R) [ Time Frame: Baseline, Week 14 ], Change in the UHDRS Total Motor Score (TMS) from baseline to the average of the Week 12 and Week 14 assessments [ Time Fra	—

Measure

Time frame

The change in Clinical Global Impression of Severity (CGI-S) score from baseline to Week 14, The change in Movement Disorders - Childhood Rating Scale (MD-CRS) Part I score from baseline to the average of the Week 12 and Week 14 assessments, The change in the Total Maximal Dystonia (TMD) score of the UHDRS from baseline to the average of the Week 12 and Week 14 assessment, Patient Global Impression of Improvement (PGI-I) score at Week 14 [ Time Frame: Week 14 ], Caregiver Global Impression of Improvement (CaGI-I) score at Week 14 [ Time Frame: Week 14 ], Clinical Global Impression of Improvement (CGI-I) score at Week 14 [ Time Frame: Week 14 ], Goal attainment score at Week 14 using the Goal Attainment Scale (GAS) [ Time Frame: Week 14 ], Change in pain assessment from baseline to Week 14 using the Faces Pain Scale-Revised (FPS-R) [ Time Frame: Baseline, Week 14 ], Change in the UHDRS Total Motor Score (TMS) from baseline to the average of the Week 12 and Week 14 assessments [ Time Fra

—

Countries

Belgium, Italy, Poland, Portugal, Spain

Outcome results

None listed