CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
RO7234292 (RG6042)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04000594
NCT04000594Phase 1Completed
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An Open-Label Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease

Hoffmann-La Roche·interventional·Posted Jun 27, 2019·Updated Oct 3, 2024

In Brief

A Phase 1 clinical trial evaluating RO7234292 (RG6042) for Huntingtons Disease. Completed, enrolled 12 participants across 3 sites in 2 countries.

Detailed Summary

Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course and recovery profile of CSF mHTT lowering in response to RO7234292 (RG6042) treatment after intrathecal (IT) administration of RO7234292 (RG6042) to patients with manifest Hungtington's disease (HD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuntingtons Disease
CountriesNetherlands, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 27, 2019
Enrollment StartSep 2, 2019
Primary CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.0 years ago

Interventions

RO7234292 (RG6042)drug

RO7234292 (RG6042) will be administered in two IT doses of the same dose level at an interval of 28 days during the treatment period (Day 1 and Day 29). Each dose of RO7234292 (RG6042) will be administered as a single IT bolus injection.