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Report for Clinical Trial NCT03842969

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's Disease

This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042.

NCT03842969 Huntington Disease
MeSH:Huntington Disease

1 Interventions

Name: RO7234292 (RG6042)

Description: Intrathecal injection
Type: Drug
Group Labels: 2

RO7234292 (RG6042) Q16W RO7234292 (RG6042) Q8W

Primary Outcomes

Measure: Percentage of Participants with Adverse Events

Time: Up to approximately 5 years

Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety.

Measure: Change From Baseline in Behavioral Findings, as Assessed by the Columbia-Suicide

Time: Baseline, Every 8 Weeks or Every 16 Weeks, and End of Treatment (up to approximately 5 years)

Description: MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0−30, where lower scores indicate greater impairment.

Measure: Change From Baseline in Cognition, using Montreal Cognitive Assessment (MoCA)

Time: Baseline, Every 16 Weeks, End of Treatment (up to approximately 5 years)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 Q16W

Upon completion of the inclusion visit, eligible patients will receive either RO7234292 (RG6042) every 8 weeks (Q8W) or RO7234292 (RG6042) every 16 weeks (Q16W) by bolus intrathecal injection. --- Q16W ---

HPO Nodes