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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A 900kDa | Biological | 6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonn | Germany | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A 900kDa | |
| FG001 | Botulinum Toxin Type A 150kDa |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A 900kDa | |
| BG001 | Botulinum Toxin Type A 150kDa | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to Treat | Posted | Mean | Standard Deviation | Points on Scale | Baseline to Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Type A 900kDa |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioneurotic oedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | Non-systematic Assessment |
This was a pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum Toxin Type A 150kDa | Biological | 6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose) |
|
|
| 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. | 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. | Baseline to Week 4 and 8 |
| Duration of Action | Median Duration for decision to reinject | Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) |
| Wiesbaden |
| Germany |
| Zwickau | Germany |
Total of all reporting groups
| years |
|
| Sex: Female, Male | One patient from group 1 withdrew consent after first injection, thus efficacy data was not gathered for this patient | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Intention to Treat | Posted | Mean | Standard Deviation | Points on Scale | Baseline to Week 8 |
|
|
|
| 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. | Intention to Treat | Posted | Mean | Standard Deviation | Points on Scale | Baseline to Week 4 and Week 8 |
|
|
|
| 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. | Intention to Treat | Posted | Mean | Standard Deviation | Points on Scale | Baseline to Week 4 and 8 |
|
|
|
| Secondary | Duration of Action | Median Duration for decision to reinject | Intention to Treat | Posted | Median | Standard Deviation | Weeks | Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) |
|
|
|
| 1 |
| 21 |
| EG001 | Botulinum Toxin Type A 150kDa | 1 | 24 |
| Carotid Artery Stenosis | Nervous system disorders | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | Non-systematic Assessment |
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| Eye Swelling | Eye disorders | Non-systematic Assessment |
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| Eyelid oedema | Eye disorders | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | Non-systematic Assessment |
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| Lid Lag | Eye disorders | Non-systematic Assessment |
|
| Sicca Syndrome | Eye disorders | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Periorbital haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Mastication Disorder | Nervous system disorders | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Change in JRS in Left Eye at Week 8 |
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| Change in JRS in Right Eye at Week 8 |
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