A Study of the Safety and Effectiveness of Experimental RO7234292 for Huntington's Disease

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 25 to 65 years old
Gender:
Any
Healthy Volunteers: No
Keywords: huntington's disease, MANIFEST HUNTINGTON'S DISEASE
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
The purpose of this study is to compare the effects of experimetnal RO7234292 in study participants with Huntington’s Disease (HD). RO7234292 is an experimental drug, which means the FDA has not approved RO7234292 for the treatment of HD or any other condition.

HD is a rare progressive neurological disease. It affects thought processes, movement, personality, and/or mood. Huntington’s Disease (HD) is caused by the production of a toxic protein within cells. RO7234292 (Study Drug) has been shown to lower levels of this protein in the first clinical trial by interfering with its production. It is hoped that reducing the production of this protein, progression of disease can be slowed or stopped. This study aims to test this idea.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Manifest HD diagnosis, defined as a DCL score of 4
  • Independence Scale (IS) score >= 70
  • Genetically confirmed disease by direct DNA testing with a CAP score >400
  • Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).

Exclusion criteria:

  • Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for about 25 to 30 months (about 2 to 2.5 years). This includes the screening period and follow-up after your last dose of study medication. During this study, you will have 16 visits.
Recruitment period
From May 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Huntingtons Disease