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

Allergan65 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Blepharospasm

Interventions

Botulinum Toxin Type A 900kDaBIOLOGICAL

6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Botulinum Toxin Type A 150kDaBIOLOGICAL

6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Bonn, Germany

Unnamed facility

Wiesbaden, Germany

Unnamed facility

Zwickau, Germany

Outcomes

Primary Outcomes

Change From Baseline to Week 4 in Blepharospasm Disability Index

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.

Time frame: Baseline to Week 4

Secondary Outcomes

Change From Baseline to Week 8 in Blepharospasm Disability Index

Blepharospasm Disability Index is a validated 5-point (0-4) scale 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.

Time frame: Baseline to Week 8

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)

Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open \> 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.

Time frame: Baseline to Week 4 and Week 8

Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score

Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect +1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement.

Data from ClinicalTrials.gov

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