Trial record 10 of 23 for:    Open Studies | "Eyelid Diseases"

Acetyl Hexapeptide-8 for Blepharospasm

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01750346
First received: December 12, 2012
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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, remaining participants will be offered the chance to have BoNT injections, and will stop taking the cream.
  • The final visit will check for any side effects from the cream or the injections.

Condition Intervention Phase
Focal Dystonia
Drug: Topical acetyl hexapeptide-8
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Placebo Controlled Double Blind Study of Acetyl Hexapeptide-8 in Treatment of Blepharospasm

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The Jankovic Blepharospasm Rating Scale at 2 month [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • JBRS at 1 mo; BDS at 1 and 2 mo; difference in JBRS between 2 and 3 months in group1; JBRS score at 6 months in group 2; different in JBRS between 6 and 7 months in group 2; blink reflex measures at 2 months [ Time Frame: 2 months ]

Estimated Enrollment: 64
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topical acetyl hexapeptide-8
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Primary blepharospasm diagnosed or confirmed by a Movement Disorders Neurologist, confirmed at the initial visit by a study investigator.
  • Only BoNT-na(SqrRoot) ve individuals will be eligible for this study.

    • Severity prompting need for treatment as determined by clinical judgment
    • At least a score of 4 on the JBRS
    • At least a score of 8 on the BDS
    • Duration of symptoms of at least 1 year, without subjective active progression by patient report
    • Concomitant therapy allowed, except injectable BoNT therapy, provided the doses remain stable throughout the study period
    • Adult patients (> 18)

EXCLUSION CRITERIA:

  • Blepharospasm associated with generalized or extensive regional dystonia
  • Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed as judged by recruiting physician
  • Local eyelid pathology precluding topical treatment
  • Received BoNT within 4 months prior to enrollment
  • Continued benefit from a prior BoNT injection (by history and self assesment)
  • Current use of cosmetic wrinkle creams
  • Prior myectomy procedure excluded
  • Pregnant women excluded. Barrier contraception will be used throughout the study for women of childbearing age, as it is not known how the use of hormonal contraceptives may interact with the study substance. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at the initial visit and periodically every 2 months for the duration of the study. Barrier contraception will be deemed necessary for the duration of the study and none after.
  • Use of other treatments for blepharospasm allowed if the doses remain constant
  • Allergy/sensitivity to study substance or vehicle.
  • Active drug or alcohol abuse or dependence
  • Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; active heart disease needing immediate intervention; active respiratory disease needing intervention; known or observed eye pathology; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
  • Cognitive inability to independently use cr(SqrRoot)(Registered Trademark)me use safely.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750346

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Codrin I Lungu, M.D. (301) 402-0976 lunguci@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01750346     History of Changes
Other Study ID Numbers: 130022, 13-N-0022
Study First Received: December 12, 2012
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Blepharospasm
Treatment
Dystonia
Acetyl-Hexapeptide

Additional relevant MeSH terms:
Eyelid Diseases
Blepharospasm
Dystonia
Dystonic Disorders
Eye Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014