A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm

OBJECTIVE: To study the efficacy of cutaneous application of Acetyl Hexapeptide-8 (AH8) in the therapy of blepharospasm. STUDY POPULATION: 22 patients with blepharospasm. DESIGN: This will be a double blind, placebo-controlled trial. Patients receiving treatment of blepharospasm with botulinum neurotoxin (BoNT) will be recruited. They will receive either the study substance or a placebo cream containing the emulsion but no active substance, in twice daily applications to the eyelids beginning the day following a BoNT injection treatment. They will continue to apply the cream and we will record the time until their condition worsens back to baseline following benefit from the injections, hypothesizing that the cream application will prolong the time until the need for the next injection by at least 3 months. OUTCOME MEASURES:: Primary: time until the Jankovic Blepharospasm Rating Scale (JBRS) reverts back to baseline. Secondary: Change in the JBRS at 6 months; Change in the JBRS at 7 months if not receiving BoNT; Change in the JBRS at 3 months; Change in the Blepharospasm Disability Scale at 6 months

- 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.

Study Location
Maryland