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Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity

NCT00819065 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-07-07

No results posted yet for this study

Summary

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.

Conditions

  • Spasticity

Interventions

DRUG

Botulinum toxin type A from laboratory Lanzhou

Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model. Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use. Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment). Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.

DRUG

Botulinum toxin type A from laboratory Allergan

Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model. Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use. Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment). Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Paulo D Picon · Hospital de Clínicas de Porto Alegre

  • Fábio C Guarany · Hospital de Clínicas de Porto Alegre

  • Nicole Ruas · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-05-31
Completion
2011-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819065 on ClinicalTrials.gov