Back to resultsComparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Primary Purpose
Blepharospasm
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Botulinum Toxin Type A 900kDa
Botulinum Toxin Type A 150kDa
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Duration of Action
Median Duration for decision to reinject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761592
Brief Title
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A 900kDa
Other Intervention Name(s)
BOTOX®
Intervention Description
6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A 150kDa
Other Intervention Name(s)
Xeomin®
Intervention Description
6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Primary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Blepharospasm Disability Index
Description
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 Outcome Measure Information:
Title
Change From Baseline to Week 8 in Blepharospasm Disability Index
Description
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
Title
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)
Description
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
Title
Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
Description
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.
Time Frame
Baseline to Week 4 and 8
Title
Duration of Action
Description
Median Duration for decision to reinject
Time Frame
Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Bonn
Country
Germany
City
Wiesbaden
Country
Germany
City
Zwickau
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
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