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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00942851
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age above 18 years
2. Diagnosis of PB made by a Movement Disorders Neurologist
3. Severity of PB prompting the need for treatment as determined by patient subjective assessment.
4. JBRS of at least 3 at initial visit.
5. BDS of at least 8 at the entry visit.
6. At least three prior successful injectable BoNT treatments, with stable interval between injections of 3 months (ie duration of response of 3 months).
EXCLUSION CRITERIA:
1. Pregnant women
2. Blepharospasm associated with a different Neurologic condition, including but not limited to generalyzed dystonia, a parkinsonian syndrome, or major brain structural abnormality, as evidenced by Neurologic exam and/or review of records
3. Skin condition resulting in loss of integrity of the skin overlying the OO or potentially interfering with cream absorption.
4. Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed
5. Abnormally long or short response to BoNT treatment in the past, ie duration of PB relief with BoNT greater than 4 months or less than 2 months.
6. Allergy to any component of the study or placebo cream.
7. Known or observed eye pathology.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00942851
Study Brief:
Protocol Section:
NCT00942851