MedTrace Logo

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

NCT00942851 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-09-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Focal Dystonia

Interventions

DRUG

Acetyl-Hexapeptide Topical Treatment

AH-8 containing topical treatment

DRUG

placebo

topical treatment NOT containing AH-8

Sponsors & Collaborators

  • BCN Peptides

    collaborator INDUSTRY

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942851 on ClinicalTrials.gov