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

NCT00819065 | Completed Phase 3

• 1 other identifier: 06336
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Botulinum toxin A; Spasticity; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

• 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.

• Incidence, severity and duration of adverse effects of each treatment, through adverse events scale.

  every follow-up visit.

• Perception of improvement of the symptoms by the patient himself or caregiver.

  every follow-up visit.

Study Arms (2)

1-BTA Lanzhou/Allergan

ACTIVE COMPARATOR

Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Lanzhou at allocation and after twelve weeks will receive the same drug from laboratory Allergan.

Drug: Botulinum toxin type A from laboratory Lanzhou; Drug: Botulinum toxin type A from laboratory Allergan

2. BTA Allergan/Lanzhou

ACTIVE COMPARATOR

Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Allergan at allocation and after twelve weeks will receive the same drug from laboratory Lanzhou.

Drug: Botulinum toxin type A from laboratory Lanzhou; Drug: Botulinum toxin type A from laboratory Allergan

Interventions

Botulinum toxin type A from laboratory Lanzhou DRUG

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.

Also known as: ProssigneTM

1-BTA Lanzhou/Allergan; 2. BTA Allergan/Lanzhou

Botulinum toxin type A from laboratory Allergan DRUG

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.

Also known as: BotoxTM

1-BTA Lanzhou/Allergan; 2. BTA Allergan/Lanzhou

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• Guarany FC, Picon PD, Guarany NR, dos Santos AC, Chiella BP, Barone CR, Fendt LC, Schestatsky P. A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. PLoS One. 2013;8(2):e56479. doi: 10.1371/journal.pone.0056479. Epub 2013 Feb 28.

  PMID: 23468866 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo D Picon

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Fábio C Guarany

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Nicole Ruas

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

BR (1)