Phase 4
Completed N=65
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Blepharospasm
Source: ClinicalTrials.gov NCT00761592 ↗
Enrolled (actual)
65
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Change From Baseline to Week 4 in Blepharospasm Disability Index — -2.8; -1.3 Points on Scale
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.
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 | — |
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. Informational only — not medical advice.