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

NCT00942851 | Completed Phase 1 Results

• 2 other identifiers: 09019309-N-0193
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Focal Dystonia

Keywords

Dystonia; Blepharospasm; Botulinum Toxin; Treatment; Clinical Trial; Focal Dystonia

Outcome Measures

Primary Outcomes (1)

• Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline

  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.

  3-7 months

Secondary Outcomes (2)

• Change in the JBRS at 3 Months

  baseline to 3 months

• % Blepharospasm Disability Scale (BDS) Change at 3 Months

  baseline to 3 months

Study Arms (2)

active

EXPERIMENTAL

AH-8 containing topical intervention

Drug: Acetyl-Hexapeptide Topical Treatment

placebo

PLACEBO COMPARATOR

topical intervention WITHOUT AH-8

Drug: placebo

Interventions

Acetyl-Hexapeptide Topical Treatment DRUG

AH-8 containing topical treatment

active

placebo DRUG

topical treatment NOT containing AH-8

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Diagnosis of PB made by a Movement Disorders Neurologist
• Severity of PB prompting the need for treatment as determined by patient subjective assessment.
• JBRS of at least 3 at initial visit.
• BDS of at least 8 at the entry visit.
• At least three prior successful injectable BoNT treatments, with stable interval between injections of 3 months (ie duration of response of 3 months).

You may not qualify if:

• Pregnant women
• Blepharospasm associated with a different Neurologic condition, including but not limited to generalyzed dystonia, a parkinsonian syndrome, or major brain structural abnormality, as evidenced by Neurologic exam and/or review of records
• Skin condition resulting in loss of integrity of the skin overlying the OO or potentially interfering with cream absorption.
• Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed
• Abnormally long or short response to BoNT treatment in the past, ie duration of PB relief with BoNT greater than 4 months or less than 2 months.
• Allergy to any component of the study or placebo cream.
• Known or observed eye pathology.

Sponsors & Collaborators

• BCN Peptides: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ben Simon GJ, McCann JD. Benign essential blepharospasm. Int Ophthalmol Clin. 2005 Summer;45(3):49-75. doi: 10.1097/01.iio.0000167238.26526.a8. No abstract available.

  PMID: 15970766 BACKGROUND

• Defazio G, Livrea P. Primary blepharospasm: diagnosis and management. Drugs. 2004;64(3):237-44. doi: 10.2165/00003495-200464030-00002.

  PMID: 14871168 BACKGROUND

• Defazio G, Livrea P. Epidemiology of primary blepharospasm. Mov Disord. 2002 Jan;17(1):7-12. doi: 10.1002/mds.1275.

  PMID: 11835433 BACKGROUND

MeSH Terms

Conditions

Dystonic Disorders; Dystonia; Blepharospasm

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Codrin Lungu, MD
• Organization: Office of the Clinical Director, NINDS, NIH

lunguci@ninds.nih.gov

301-496-5295

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2009
• First Posted: July 21, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 6, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-08

Locations

US (1)