Spasticity Clinical Trial
Official title:
Randomized Double-blind Clinical Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
Verified date | July 2011 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
The purpose of this study is to compare the effectiveness between two commercial formulations of botulinum toxin type A in the treatment of spasticity through the Ashworth scale.
Status | Completed |
Enrollment | 56 |
Est. completion date | June 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - To be included, patients must have diagnosis of Spasticity by IC10 criteria. - We will enroll patients on current treatment for spasticity at the Spasticity outpatient clinic of HCPA, already in treatment with BTA or starting that treatment based on their doctors' decision, who are willing to participate in the trial by signing an informed consent form. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle tonus reduction will be assessed by the Ashworth Scale. | time of allocation, four, twelve, sixteen and twenty-four weeks after first application of toxin. | No | |
Secondary | Life quality will be assessed by WHOQOL-Bref, YQOL-R and Children's Life Quality assessment questionnaire, respecting the age of the patient. | time of allocation, twelve and twenty-four weeks after first application of toxin. | No | |
Secondary | Functional capability will be evaluated through the Functional Independence Measure Scale (FIM) for adults and PEDI scale for children. | time of allocation, twelve and twenty-four weeks after first application of toxin. | No | |
Secondary | Incidence, severity and duration of adverse effects of each treatment, through adverse events scale. | every follow-up visit. | Yes | |
Secondary | Perception of improvement of the symptoms by the patient himself or caregiver. | every follow-up visit. | No |
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