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NCT01750346 · ClinicalTrials.gov registry record · Phase 2
Acetyl Hexapeptide-8 for Blepharospasm
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01750346 is a Phase 2 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 8 participants.
The verdict
NCT01750346, a Phase 2 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
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, re
Interventions
- DRUG Placebo
- DRUG Topical acetyl hexapeptide-8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01750346
The ClinicalTrials.gov registry entry for NCT01750346 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01750346 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01750346 about?
NCT01750346 is a clinical study titled "Acetyl Hexapeptide-8 for Blepharospasm". 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 ...
What is the current status of trial NCT01750346?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2012-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01750346?
The interventions under investigation include: Placebo (DRUG), Topical acetyl hexapeptide-8 (DRUG).
Who is sponsoring clinical trial NCT01750346?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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