A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-10-08

Brief Summary

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This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7234292 administered intrathecally to adult patients with Huntington's Disease.

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Detailed Description

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Conditions

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Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RO7234292 Monthly

RO7234292 is administered every 28 days intrathecally for 14 months.

Group Type EXPERIMENTAL

RO7234292 (RG6042)

Intervention Type DRUG

Intrathecal injection

RO7234292 Bimonthly

RO7234292 is administered every 56 days intrathecally for 14 months following 2 monthly doses to serve as a loading dose.

Group Type EXPERIMENTAL

RO7234292 (RG6042)

Intervention Type DRUG

Intrathecal injection

Interventions

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RO7234292 (RG6042)

Intrathecal injection

Intervention Type DRUG

Other Intervention Names

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Tominersen

Eligibility Criteria

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Inclusion Criteria

* Must have completed dosing in ISIS 443139-CS1

Exclusion Criteria

* Any new condition or worsening of existing condition that could make the patient unsuitable for participation or interfere with the patient participating in and/or completing the study

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No