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

This study has been completed.
Sponsor:
Collaborator:
BCN Peptides
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT00942851
First received: July 18, 2009
Last updated: August 3, 2012
Last verified: August 2012
Results First Received: May 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Focal Dystonia
Interventions: Drug: Acetyl-Hexapeptide Topical Treatment
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
Placebo

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

Twice daily application to the eyelids in standardized fashion.


Participant Flow:   Overall Study
    Active   Placebo
STARTED   12   12 
COMPLETED   12   11 
NOT COMPLETED   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Active AH-8 containing topical intervention
Placebo topical intervention WITHOUT AH-8
Total Total of all reporting groups

Baseline Measures
   Active   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   11   21 
>=65 years   2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.59  (8.46)   55.87  (8.25)   56.73  (8.22) 
Gender 
[Units: Participants]
     
Female   12   2   14 
Male   0   10   10 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline   [ Time Frame: 3-7 months ]

2.  Secondary:   Change in the JBRS at 3 Months   [ Time Frame: baseline to 3 months ]

3.  Secondary:   % Blepharospasm Disability Scale (BDS) Change at 3 Months   [ Time Frame: baseline to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Codrin Lungu, MD
Organization: Office of the Clinical Director, NINDS, NIH
phone: 301-496-5295
e-mail: lunguci@ninds.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00942851     History of Changes
Other Study ID Numbers: 090193
09-N-0193
Study First Received: July 18, 2009
Results First Received: May 29, 2012
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration