Acetyl Hexapeptide-8 for Blepharospasm
- 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.
- To see if AH-8 cream can improve the symptoms of blepharospasm.
- Individuals at least 18 years of age who have blepharospasm that is severe enough to require treatment.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo Controlled Double Blind Study of Acetyl Hexapeptide-8 in Treatment of Blepharospasm|
- The Jankovic Blepharospasm Rating Scale at 2 month [ Time Frame: 2 months ]
- JBRS at 1 mo; BDS at 1 and 2 mo; difference in JBRS between 2 and 3 months in group1; JBRS score at 6 months in group 2; different in JBRS between 6 and 7 months in group 2; blink reflex measures at 2 months [ Time Frame: 2 months ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Drug: Topical acetyl hexapeptide-8
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|Contact: Codrin I Lungu, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Codrin I Lungu, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|