A Phase 1/2 interventional study of Acetyl-Hexapeptide Topical Treatment and placebo in Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-06.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 1/2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
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
95 studies on the registry are indexed under Dystonic Disorders; 19 are open to participants now.
This study's enrollment of 24 is close to the median of 24 across 45 interventional studies indexed under Dystonic Disorders.
Browse Dystonic Disorders studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
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Age above 18 years
EXCLUSION CRITERIA:
AH-8 containing topical intervention
Drug: Acetyl-Hexapeptide Topical Treatment
topical intervention WITHOUT AH-8
Drug: placebo
AH-8 containing topical treatment
topical treatment NOT containing AH-8
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.
Time frame: 3-7 months
Change in the JBRS at 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.
Time frame: baseline to 3 months
% Blepharospasm Disability Scale (BDS) Change at 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.
Time frame: baseline to 3 months
| Milestone | Active | Placebo |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 11 |
| Not completed | 0 | 1 |
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.
| month | Active Ingredient- AH8 | Placebo |
|---|---|---|
| Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline | 3.71 ± 1.48 | 3.03 ± .23 |
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.
| points | Active Ingredient- AH8 | Placebo |
|---|---|---|
| Change in the JBRS at 3 Months | 1.09 ± 0.7 | 0.92 ± 2.07 |
% 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.
| percentage change | Active | Placebo |
|---|---|---|
| % Blepharospasm Disability Scale (BDS) Change at 3 Months | 30.89 ± 37.3 | 32.32 ± 31.13 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | — | 0/12 (0%) | 2/12 (16.7%) |
| Placebo | — | 0/12 (0%) | 2/12 (16.7%) |
| Event | Active | Placebo |
|---|---|---|
| eyelid irritationSkin and subcutaneous tissue disorders | 2/12 | 2/12 |
| Age, Categorical(Participants) | Active | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 11 | 21 |
| >=65 years | 2 | 1 | 3 |
| Age Continuous(years) | Active | Placebo | Total |
|---|---|---|---|
| Mean | 57.59 ± 8.46 | 55.87 ± 8.25 | 56.73 ± 8.22 |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 12 | 2 | 14 |
| Male | 0 | 10 | 10 |
| Region of Enrollment(participants) | Active | Placebo | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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