Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients

Spasticity Clinical Trial

— B-CAUSE  

Official title:

An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390206
• Other study ID #: A-38-52120-202
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: September 29, 2017
• Start date: June 2015
• Est. completion date: August 28, 2017

Study information

• Verified date: September 2017
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

Description:

As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.

This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.

This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Time between last documented stroke (either haemorrhagic or ischemic) and study inclusion date equal or longer than 1 year

• Documented upper limb spasticity, with or without lower limb spasticity

• Naive to BoNT-A injections for spasticity treatment

• Provide written informed consent (signed by the patient or his legal representative) prior to any study-related procedure

Exclusion Criteria:

• Previous surgical procedure for spasticity treatment, including neurotomy, rhizotomy and intrathecal pump implants

• Previous phenol injection and/or indication to receive phenol during the study duration

• Contraindications to any BoNT-A preparations

• Patient and/or caregiver unable to comply with the study requirements

• The patient has already been included in the study

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
Brazil	Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará	Belém
Brazil	Centro Catarinense de Reabilitação	Florianópolis
Brazil	Centro de Reabilitação e Readaptação Dr. Henrique Santillo	Goiânia
Brazil	Clinica Neurológica e Neurocirúrgica de Joinville	Joinville
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto
Brazil	Hospital Universitário Clementino Fraga Filho (HUCFF)	Rio de Janeiro
Brazil	Instituto de Reabilitação Lucy Montoro - FAMERP	São José do Rio Preto
Brazil	HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação	São Paulo
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo
Brazil	Hospital São Paulo - UNIFESP	São Paulo
Brazil	Irmandade da Santa Casa de Misericórida de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Goal Achievement Score (GAS).		3 and 6 months
Secondary	Change from baseline in pain according to Verbal Numerical Scale (VNS).		Baseline and 3 months
Secondary	Change from baseline in Modified Ashworth Scale (MAS) score		Baseline and 3 months
Secondary	Change from baseline in functional independence according to Barthel index score		Baseline and 3 months
Secondary	Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire		Baseline and 3 months