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

Blepharospasm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761592
• Other study ID #: ALLBL001
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2008
• Last updated: October 25, 2013
• Start date: July 2006
• Est. completion date: January 2008

Study information

• Verified date: October 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm

Intervention

Biological:
• Botulinum Toxin Type A 900kDa
6 to 16 injections, with maximum of 21, at a dose of =20U/eye (=40U total dose)
• Botulinum Toxin Type A 150kDa
6 to 16 injections, with a maximum of 21, at a dose of =20U/eye (=40U total dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 4	No
Secondary	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.	Baseline to Week 8	No
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)	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.	Baseline to Week 4 and Week 8	No
Secondary	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.	Baseline to Week 4 and 8	No
Secondary	Duration of Action	Median Duration for decision to reinject	Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)	No