Protocol Number: 09-N-0193

Title:

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

Number:

09-N-0193

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 muscles.

- Acetyl Hexapeptide-8 (AH-8) is the active ingredient in a number of cosmetic creams used to treat wrinkles, and is marketed under the trade name Argireline(Copyright). Like BoNT, AH-8 works to weaken the muscles, but is available as a skin cream instead of an injection. AH-8 has never been used to treat people with blepharospasm.

Objectives:

- To determine if AH-8 can be used as part of a treatment regimen for blepharospasm.

Eligibility:

- Individuals 18 years of age and older who have blepharospasm and have been receiving successful treatment with botulinum toxin injections.

Design:

- Participants will be involved in the study for a maximum of 7 months.

- Patients will have a complete physical and neurological exam, and will be asked questions about their blepharospasm. Patients will then receive BoNT injections in the same areas of the muscle around the eye and at the same doses that have been effective previously.

- After the injections, patients will receive a container of either the active cream (with AH-8) or cream without AH-8, and will be instructed on how to apply it.

- Patients will return 1 month after the first visit for another neurologic exam and questions, and will be asked about any side effects. Another supply of cream will be given.

- Five additional visits will take place on a monthly basis, and patients will be given additional supplies of the cream as needed. Patients will stop participating in the study if they require another BoNT injection for blepharospasm. The study will end after 7 months.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

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.

Special Instructions:

Currently Not Provided

Keywords:

Dystonia

Blepharospasm

Botulinum Toxin

Treatment

Clinical Trial

Recruitment Keyword(s):

Focal Dystonia

Blepharospasm

Condition(s):

Focal Dystonia

Investigational Drug(s):

Acetyl-Hexapeptide 8

Investigational Device(s):

None

Intervention(s):

Drug: Acetyl-Hexapeptide Topical Treatment

Drug: Acetyl-Hexapeptide 8

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Ben Simon GJ, McCann JD. Benign essential blepharospasm. Int Ophthalmol Clin. 2005 Summer;45(3):49-75.

Defazio G, Livrea P. Primary blepharospasm: diagnosis and management. Drugs. 2004;64(3):237-44.

Defazio G, Livrea P. Epidemiology of primary blepharospasm. Mov Disord. 2002 Jan;17(1):7-12.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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