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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT02390206

Collaborator

(none)

239

Enrollment

Locations

26.9

Duration (Months)

21.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spasticity

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

239 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 28, 2017

Actual Study Completion Date :

Aug 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Botulinum toxin type A (BoNT-A) injection Naïve Subjects naïve to BoNT-A treatment. Investigators follow their individual injection protocol for treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines).

Outcome Measures

Primary Outcome Measures

Change in Goal Achievement Score (GAS). [3 and 6 months]

Secondary Outcome Measures

Change from baseline in pain according to Verbal Numerical Scale (VNS). [Baseline and 3 months]
Change from baseline in Modified Ashworth Scale (MAS) score [Baseline and 3 months]
Change from baseline in functional independence according to Barthel index score [Baseline and 3 months]
Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire [Baseline and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará	Belém	Brazil	66045-110
2	Centro Catarinense de Reabilitação	Florianópolis	Brazil	88025-301
3	Centro de Reabilitação e Readaptação Dr. Henrique Santillo	Goiânia	Brazil	74653-230
4	Clinica Neurológica e Neurocirúrgica de Joinville	Joinville	Brazil	89202-165
5	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto	Brazil	14048-900
6	Hospital Universitário Clementino Fraga Filho (HUCFF)	Rio de Janeiro	Brazil	21941-913
7	Instituto de Reabilitação Lucy Montoro - FAMERP	São José do Rio Preto	Brazil	1591-240
8	Irmandade da Santa Casa de Misericórida de São Paulo	São Paulo	Brazil	01221-010
9	Hospital Alemão Oswaldo Cruz	São Paulo	Brazil	01323-903
10	Hospital São Paulo - UNIFESP	São Paulo	Brazil	04024-002
11	HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação	São Paulo	Brazil	05403-900