Status:
COMPLETED
A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
BCN Peptides
Conditions:
Focal Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Blepharospasm is caused by excessive contraction of the muscles that close the eye. It can be treated with injections of botulinum neurotoxin (BoNT), which works by weakening those musc...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age above 18 years
- Diagnosis of PB made by a Movement Disorders Neurologist
- Severity of PB prompting the need for treatment as determined by patient subjective assessment.
- JBRS of at least 3 at initial visit.
- BDS of at least 8 at the entry visit.
- 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:
- Pregnant women
- 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
- Skin condition resulting in loss of integrity of the skin overlying the OO or potentially interfering with cream absorption.
- Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed
- 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.
- Allergy to any component of the study or placebo cream.
- Known or observed eye pathology.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00942851
Start Date
July 1 2009
End Date
October 1 2010
Last Update
September 6 2012
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892