Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06873334
Eligibility Criteria:
Inclusion Criteria:
* You must be 25 years or older.
* You must have Huntington's Disease confirmed through genetic testing, with a specific gene change (CAG repeat of 40 or more).
* Total Functional Capacity (TFC) score of 10 or more).
* Total Motor Score (TMS) of 6 or more).
* Independence Score (IS) of 70 or more).
* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.
* Men must agree to use birth control during the study and for 90 days after the last dose.
* You must agree to sign a consent form and follow the study's rules and schedule.
Exclusion Criteria:
* You have other serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
* You have a condition that interferes with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.
* You have cancer, except for some types of skin cancer, or a history of cancer in the last five years.
* You have severe allergies or have reacted badly to similar drugs in the past.
* You are taking medications or treatments that might interfere with the study.
* You've been in another study or taken experimental drugs in the last two months (or longer for some drugs).
* You have had any kind of gene therapy.
* You have a history of suicidal thoughts, severe depression, or have attempted suicide in the past year.
* Your liver function tests show significant abnormalities.
* You have tested positive for hepatitis B, hepatitis C, or HIV.
* You are pregnant, breastfeeding, or planning to become pregnant during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT06873334
Study Brief:
Protocol Section:
NCT06873334