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The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment. | ||
| PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health Research Institute | Phoenix | Arizona | 85006 | United States | ||
| Neurological Institute |
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| Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment. |
| Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment. |
| Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point. |
| Patient assessment of benefit and need for re-treatment, evaluated at the end of the study. |
| Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study. |
| To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations. |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| The Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| UCLA/Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
| McKnight Brain Institute | Gainesville | Florida | 32610 | United States |
| Plastic Eye Surgery Association | Pensacola | Florida | 32504 | United States |
| Rush Presbyterian/St Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Columbia-Presbyterian Medical Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Ophthlamic Surgeons and Consultants of Ohio, Inc | Columbus | Ohio | 43215 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Parkinson's Disease Center and Movement Disorders Clinic | Houston | Texas | 77030 | United States |
| Center for Facial Appearances | Salt Lake City | Utah | 84102 | United States |
| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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