Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

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Brief Title

Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm


Brief Summary

      This pilot study estimates the treatment effects of two different types of botulinum toxin
      type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive
      contraction of the muscles around the eye and can lead to repetitive blinking or sustained
      closure of the eyelids.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change From Baseline to Week 4 in Blepharospasm Disability Index

Secondary Outcome

 Change From Baseline to Week 8 in Blepharospasm Disability Index

Condition

Blepharospasm

Intervention

Botulinum Toxin Type A 900kDa

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

65

Start Date

July 2006

Completion Date

January 2008

Primary Completion Date

January 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosed with benign essential blepharospasm

          -  Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required,
             in the investigators opinion, the same dose at the study injection visit.

          -  Combined Jankovic Rating Score of >2

        Exclusion Criteria:

          -  Female subjects who were pregnant, breastfeeding, or who were of childbirth potential
             and not practicing birth control.

          -  Profound atrophy of the muscles in the target area(s) of injection.

          -  Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other
             disease that might interfere with neuromuscular function.

          -  Known significantly impaired renal and/or hepatic function
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Director, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00761592

Organization ID

ALLBL001


Responsible Party

Sponsor

Study Sponsor

Allergan


Study Sponsor

Medical Director, Study Director, Allergan


Verification Date

October 2013