Primary outcomeMean· 3-7 months
Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline
| Group | Value (month) | Spread |
|---|---|---|
| Active Ingredient- AH8 | 3.71 | 1.48 |
| Placebo | 3.03 | .23 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataA Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm
This trial does not test a peptide that PepBank tracks.
- Names Argireline (acetyl hexapeptide-8), does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 24 participants (actual)
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS) · Nih
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Jul 2009
- Primary completion
- Oct 2010
- Completion
- Oct 2010
- First posted
- 21 Jul 2009 (estimated)
- Last update posted
- 6 Sept 2012 (estimated)
- Conditions
- Focal Dystonia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- Ph 1/2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Acetyl-Hexapeptide Topical TreatmentDrug
- placeboDrug
Arms2
Experimental
active
AH-8 containing topical intervention
Placebo comparator
placebo
topical intervention WITHOUT AH-8
Primary outcomes1
Outcomes the sponsor listed as primary.
Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline
Time frame · 3-7 months
Registry description
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.
Secondary outcomes(2)
Change in the JBRS at 3 Months
Time frame · baseline to 3 months
Registry description
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
Registry description
% 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· baseline to 3 months
Change in the JBRS at 3 Months
| Group | Value (points) | Spread |
|---|---|---|
| Active Ingredient- AH8 | 1.09 | 0.7 |
| Placebo | 0.92 | 2.07 |
Secondary outcomeMean· baseline to 3 months
% Blepharospasm Disability Scale (BDS) Change at 3 Months
| Group | Value (percentage change) | Spread |
|---|---|---|
| Active | 30.89 | 37.3 |
| Placebo | 32.32 | 31.13 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ActiveAH-8 containing topical intervention | – | 0 / 12 | 2 / 12 |
| Placebotopical intervention WITHOUT AH-8 | – | 0 / 12 | 2 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA:
1. Age above 18 years
2. Diagnosis of PB made by a Movement Disorders Neurologist
3. Severity of PB prompting the need for treatment as determined by patient subjective assessment.
4. JBRS of at least 3 at initial visit.
5. BDS of at least 8 at the entry visit.
6. At least three prior successful injectable BoNT treatments, with stable interval between injections of 3 months (ie duration of response of 3 months).
EXCLUSION CRITERIA:
1. Pregnant women
2. 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
3. Skin condition resulting in loss of integrity of the skin overlying the OO or potentially interfering with cream absorption.
4. Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed
5. 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.
6. Allergy to any component of the study or placebo cream.
7. Known or observed eye pathology.
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