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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00277602
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more
* UHDRS Motor score of at least 5 points
* UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care
* Females require a negative blood pregnancy test at inclusion
Exclusion Criteria:
* Any forms of chorea other than Huntington's disease
* Patients on antichoreic treatment within one month prior to entry or foreseen to require such treatment within the first 3 months after randomization (antichoreic medication is prohibited during entire study)
* Other unacceptable prior/concomitant medications
* Uncontrolled major psychiatric disorders, in particular uncontrolled major depression (DSM IV definition)
* Drug or alcohol dependence and/or abuse (DSM IV definition) within the past 6 months
* Any other concomitant disease with a reasonable possibility to interfere with the study
* Females who are breast-feeding, not sterilized, at least one year postmenopausal or don't use an adequate contraceptive method for at least one month prior to and during study participation
* Participation in another clinical study with any investigational drug within 30 days prior to study screening
* Prior exposure to riluzole
* ALT and/or AST and/or Total Bilirubin levels greater than 1.5 times the upper limits of normal range, or hepatic disease other than Gilbert's disease
* Creatinine serum concentrations above 200 µmol/l (resp. 2,3 mg/dl) or hematology parameters as follows: Hemoglobin smaller 11 g/dl for males resp. smaller 10 g/dl for females, or White Blood Cell smaller 3,5 x 10000000000/l
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT00277602
Study Brief:
Protocol Section:
NCT00277602