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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00942851
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Active 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.

Participant Flow:   Overall Study
    Active   Placebo
STARTED   12   12 
COMPLETED   12   11 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   11   21 
>=65 years   2   1   3 
[Units: Years]
Mean (Standard Deviation)
 57.59  (8.46)   55.87  (8.25)   56.73  (8.22) 
[Units: Participants]
Female   12   2   14 
Male   0   10   10 
Region of Enrollment 
[Units: Participants]
United States   12   12   24 

  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

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
No text entered.

  More Information

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


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
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