CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Acetyl-Hexapeptide Topical Treatment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00942851
NCT00942851Phase 2Completed

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

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Jul 21, 2009·Updated Sep 6, 2012

In Brief

A Phase 2 clinical trial evaluating Acetyl-Hexapeptide Topical Treatment and placebo for Focal Dystonia. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Dystonia
CountriesUnited States
CollaboratorsBCN Peptides

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.9 years ago

Interventions

Acetyl-Hexapeptide Topical Treatmentdrug

AH-8 containing topical treatment

placebodrug

topical treatment NOT containing AH-8