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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)