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

Allergan

Status and phase: Completed; Phase 4

Conditions: Blepharospasm

Treatments: Biological: Botulinum Toxin Type A 150kDa; Biological: Botulinum Toxin Type A 900kDa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761592

ALLBL001

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

65 participants in 2 patient groups

1

Active Comparator group

Treatment:

Biological: Botulinum Toxin Type A 900kDa

2

Active Comparator group

Treatment:

Biological: Botulinum Toxin Type A 150kDa