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NCT00942851 · ClinicalTrials.gov registry record · Phase 1
A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm
A Phase 1 study of Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00942851: Completed Phase 1 study of Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00942851 is a Phase 1 study of Focal Dystonia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants, below the 30-participant average among 8 other Focal Dystonia trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942851, a Phase 1 study of Focal Dystonia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time. Return to baseline value represents loss of benefit from BoNT injection. The time to return to baseline JBRS is an indication of added benefit from the topical intervention.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Acetyl-Hexapeptide Topical Treatment
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00942851 record still lists
NCT00942851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 30-participant average among 8 other Focal Dystonia trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Focal Dystonia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00942851 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00942851 about?
NCT00942851 is a clinical study titled "A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm". 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 t...
What is the current status of trial NCT00942851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-07. Estimated completion is 2010-10.
What conditions does trial NCT00942851 study?
This clinical trial studies the following conditions: Focal Dystonia.
What interventions are being tested in trial NCT00942851?
The interventions under investigation include: placebo (DRUG), Acetyl-Hexapeptide Topical Treatment (DRUG).
Who is sponsoring clinical trial NCT00942851?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00942851 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00942851's enrollment target sits among peer trials
24 5th of 8 higher than 4 of 8 other Focal Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Dystonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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