NCT03842969

An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Entry into the study should occur at the time the participant completes participation in one of the preceding studies. Upon completion of the inclusion visit, eligible participants will receive either RO7234292 (RG6042) every 8 weeks (Q8W) or RO7234292 (RG6042) every 16 weeks (Q16W) by the bolus intrathecal injection.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	RO7234292 (RG6042)	Intrathecal injection

Timeline

• Start date: 2019-04-23
• Primary completion: 2022-03-25
• Completion: 2022-03-30
• First posted: 2019-02-15
• Last updated: 2023-08-31
• Results posted: 2023-08-31

Locations

38 sites across 8 countries: United States, Austria, Canada, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study