Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Blepharospasm
- Sponsor
- Allergan
- Enrollment
- 65
- Primary Endpoint
- Change From Baseline to Week 4 in Blepharospasm Disability Index
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change From Baseline to Week 4 in Blepharospasm Disability Index
Time Frame: Baseline to Week 4
Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.
Secondary Outcomes
- Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)(Baseline to Week 4 and Week 8)
- Change From Baseline to Week 8 in Blepharospasm Disability Index(Baseline to Week 8)
- Duration of Action(Interval between initial injection (Week 0) and final visit (Week 11 through Week 14))
- Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score(Baseline to Week 4 and 8)