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

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ClinicalTrials.gov Identifier: NCT00942851
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Collaborator:
BCN Peptides
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Focal Dystonia
Interventions Drug: Acetyl-Hexapeptide Topical Treatment
Drug: placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Placebo
Hide Arm/Group Description Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.

Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.

Twice daily application to the eyelids in standardized fashion.

Period Title: Overall Study
Started 12 12
Completed 12 11
Not Completed 0 1
Arm/Group Title Active Placebo Total
Hide Arm/Group Description AH-8 containing topical intervention topical intervention WITHOUT AH-8 Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  83.3%
11
  91.7%
21
  87.5%
>=65 years
2
  16.7%
1
   8.3%
3
  12.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
57.59  (8.46) 55.87  (8.25) 56.73  (8.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
12
 100.0%
2
  16.7%
14
  58.3%
Male
0
   0.0%
10
  83.3%
10
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline
Hide 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.
Time Frame 3-7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ingredient- AH8 Placebo
Hide Arm/Group Description:
subjects receiving active intervention, ie topical cream containing 0.005% AH-8
subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: month
3.71  (1.48) 3.03  (.23)
2.Secondary Outcome
Title Change in the JBRS at 3 Months
Hide 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One placebo arm participant dropped out due to unrelated personal problems
Arm/Group Title Active Ingredient- AH8 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: points
1.09  (0.7) 0.92  (2.07)
3.Secondary Outcome
Title % Blepharospasm Disability Scale (BDS) Change at 3 Months
Hide 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One placebo arm participant discontinued study due to unrelated personal problems
Arm/Group Title Active Placebo
Hide Arm/Group Description:
AH-8 containing topical intervention
topical intervention WITHOUT AH-8
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: percentage change
30.89  (37.3) 32.32  (31.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Placebo
Hide Arm/Group Description AH-8 containing topical intervention topical intervention WITHOUT AH-8
All-Cause Mortality
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Active Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Active Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      2/12 (16.67%)    
Skin and subcutaneous tissue disorders     
eyelid irritation  [1]  2/12 (16.67%)  2 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
[1]
4 subjects (2 active arm and 2 placebo arm) experience minor self-limited eyelid irritation. Ophthalmology consultation was obtained in all cases. No change in the study procedure was needed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Codrin Lungu, MD
Organization: Office of the Clinical Director, NINDS, NIH
Phone: 301-496-5295
EMail: lunguci@ninds.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00942851    
Other Study ID Numbers: 090193
09-N-0193
First Submitted: July 18, 2009
First Posted: July 21, 2009
Results First Submitted: May 29, 2012
Results First Posted: September 6, 2012
Last Update Posted: September 6, 2012