Acetyl Hexapeptide-8 for Blepharospasm

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Focal Dystonia

In brief

Background: \- Blepharospasm is caused by excessive contraction of the muscles that close the eye. One treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT, acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream. AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles. Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see if it can be a more effective treatment. Objectives: \- To see if AH-8 cream can improve the symptoms of blepharospasm. Eligibility: \- Individuals at least 18 years of age who have blepharospasm that is severe enough to require treatment. Design: * This study will involve up to eight study visits. * Participants will be screened with a physical exam and medical history. They will answer questions about their symptoms. They will also have a blink test to see how severe the blepharospasm is. At this visit, participants will receive one of three types of cream. One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the other will be a placebo (no AH-8). * One month later, participants will have a followup visit, with tests similar to the first visit. They will also receive more of the cream. * One month later, participants will have another visit with the same tests. They will be videotaped at this visit to study their facial movements. Those who have responded to the treatment will continue to use the cream. Those who have not responded will be offered the chance to have BoNT injections, and will stop taking the cream. * One month later, participants who had BoNT injections will have a final visit to check for possible side effects. Those who continued to take the cream will continue on the study. * The fifth and sixth visits will involve the same tests as before. At the seventh visit, remaining participants will be offered the chance to have BoNT injections, and will stop taking the cream. * The final visit will check for any side effects from the cream or the injections.

Key facts

Study ID: NCT01750346
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 8
Starts: 2012-11-01
Expected to finish: 2015-05-01
Last updated by the study team: 2016-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Blepharospasm associated with generalized or extensive regional dystonia
Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed as judged by recruiting physician
Local eyelid pathology precluding topical treatment
Received BoNT within 4 months prior to enrollment
Continued benefit from a prior BoNT injection (by history and self assesment) Current use of cosmetic wrinkle creams
Prior myectomy procedure excluded
Pregnant women excluded. Barrier contraception will be used throughout the study for women of childbearing age, as it is not known how the use of hormonal contraceptives may interact with the study substance. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at the initial visit and periodically every 2 months for the duration of the study. Barrier contraception will be deemed necessary for the duration of the study and none after.
Use of other treatments for blepharospasm allowed if the doses remain constant
Allergy/sensitivity to study substance or vehicle.
Active drug or alcohol abuse or dependence
Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; active heart disease needing immediate intervention; active respiratory disease needing intervention; known or observed eye pathology; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
Cognitive inability to independently use cr(SqrRoot)(Registered Trademark)me use safely.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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