Phase 4
N=65
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Blepharospasm
Bottom Line
View on ClinicalTrials.gov: NCT00761592 ↗Enrolled (actual)
65
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Change From Baseline to Week 4 in Blepharospasm Disability Index — -2.8; -1.3 Points on Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botulinum Toxin Type A 900kDa (Biological); Botulinum Toxin Type A 150kDa (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Blepharospasm Disability Index |
-2.8; -1.3 | — |
| SECONDARY Change From Baseline to Week 8 in Blepharospasm Disability Index |
-1.3; -0.8 | — |
| SECONDARY 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) |
-2.3; -1.5; -2.2; -1.5; -1.9; -1.3 | — |
| SECONDARY Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score |
1.13; 0.52; -0.16; 0.19 | — |
| SECONDARY Duration of Action |
13.1; 13.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00761592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.