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

Phase 4

Completed

• Conditions: Blepharospasm
• Interventions: Biological: Botulinum Toxin Type A 900kDa; Biological: Botulinum Toxin Type A 150kDa

• Registration Number: NCT00761592
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-29
• Results First Submitted: 2009-01-30
• Results First Submitted QC: 2009-05-18
• Results First Posted: 2009-07-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Botulinum Toxin Type A 900kDa	-
2	Botulinum Toxin Type A 150kDa	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Blepharospasm Disability Index	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 Outcome Measures

Name	Time	Method
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	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.
Change From Baseline to Week 8 in Blepharospasm Disability Index	Baseline to Week 8	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.
Duration of Action	Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)	Median Duration for decision to reinject
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score	Baseline to Week 4 and 8	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.