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

Study Identifier
ALLBL001
CT.gov Identifier
NCT00761592
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • Botulinum Toxin Type A 900kDa
  • Botulinum Toxin Type A 150kDa
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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 Locations

    Location
    Status
    Location
    Bonn, Germany
    Status
    Not applicable
    Location
    Wiesbaden, Germany
    Status
    Not applicable
    Location
    Zwickau, Germany
    Status
    Not applicable