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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

    Detailed Summary:

    OBJECTIVE:

    To study the efficacy of cutaneous application of Acetyl Hexapeptide-8 (AH8) in the therapy of blepharospasm.

    STUDY POPULATION:

    22 patients with blepharospasm.

    DESIGN:

    This will be a double blind, placebo-controlled trial. Patients receiving treatment of blepharospasm with botulinum neurotoxin (BoNT) will be recruited. They will receive either the study substance or a placebo cream containing the emulsion but no active substance, in twice daily applications to the eyelids beginning the day following a BoNT injection treatment. They will continue to apply the cream and we will record the time until their condition worsens back to baseline following benefit from the injections, hypothesizing that the cream application will prolong the time until the need for the next injection by at least 3 months.

    OUTCOME MEASURES::

    Primary: time until the Jankovic Blepharospasm Rating Scale (JBRS) reverts back to baseline.

    Secondary: Change in the JBRS at 6 months; Change in the JBRS at 7 months if not receiving BoNT; Change in the JBRS at 3 months; Change in the Blepharospasm Disability Scale at 6 months


    Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

    Current Primary Outcome: Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline [ Time Frame: 3-7 months ]

    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.


    Original Primary Outcome: Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline

    Current Secondary Outcome:

    • Change in the JBRS at 3 Months [ Time Frame: baseline to 3 months ]
      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.
    • % Blepharospasm Disability Scale (BDS) Change at 3 Months [ Time Frame: baseline to 3 months ]
      % BDS change at 3 months. The BDS is a quality of life scale ranging from 0 (no symptoms) to 26 (maximum impact of symptoms on quality of life). The questions are specific for impairment related to blepharospasm. We compared the percentage change over three months in the active and placebo arms.


    Original Secondary Outcome: Change in the JBRS at 6 months; Change in the JBRS at 7 months if not receiving BoNT; Change in the JBRS at 3 months; Change in the Blepharospasm Disability Scale at 6 months.

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: July 18, 2009
    Date Started: July 2009
    Date Completion:
    Last Updated: August 3, 2012
    Last Verified: August 2012