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:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT01543750
Eligibility Criteria:
Inclusion Criteria:
Patients will be included if they:
* Have EA2 genetically confirmed to harbor mutations in CACNA1A
* Are ≥ 18 years of age
* Are not taking acetazolamide (because of intolerance, poor response, or allergy)
* Are able to maintain a daily log of ataxia episode(s) and report daily by using an Interactive Voice Recording System (IVR) throughout the study
* Experience ≥ 3 ataxia episodes per month during the two-month screening period to qualify for randomization
Exclusion Criteria:
Patients will be excluded if they:
* Have seizures or a history of seizures
* Have first-degree relatives with EA2 and seizures
* Have renal disease with impaired function (Creatinine clearance CrCl≤50ml/min)
* Are pregnant or breast feeding (women of childbearing age will be tested for pregnancy and must be using birth control)
* Are unable to comply with the study requirement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01543750
Study Brief:
Protocol Section:
NCT01543750