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:
NCT04478734
Eligibility Criteria:
Inclusion Criteria:
* Patients of legal age with manifest Huntington's disease with motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric; and genetic confirmation of a number of repetitions of the cytosine-adenine-guanine trinucleotide (CAG triplet) in the HTT gene (coding for HTT) greater than or equal to 39
* Patients should be capable of giving informed consent and attending the planned visit of the study.
* Women of childbearing age should obtain a negative result in the serum or urine pregnancy test at the screening visit. They must also accept the use of appropriate contraceptive methods during the course of the clinical trial and men who have a partner of childbearing age, accept the use of contraceptive methods
Exclusion Criteria:
* Medical comorbidities considered clinically significant by the clinical judgment of the investigators.
* Pregnancy or lactation
* Patients with HD dependents on the basic routine daily life activities (UHDRS TFC \< 7) or a severe cognitive decline.
* Active psychosis at the moment of the screening evaluation.
* Severe renal failure.
* Patients previously treated with thiamine and/or biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04478734
Study Brief:
Protocol Section:
NCT04478734