Status:
COMPLETED
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Lead Sponsor:
Allergan
Conditions:
Blepharospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 musc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00761592
Start Date
July 1 2006
End Date
January 1 2008
Last Update
November 19 2013
Active Locations (3)
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1
Bonn, Germany
2
Wiesbaden, Germany
3
Zwickau, Germany