Clinical trial NCT02390206: Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Keywords: Stroke
Spasticity
Botulinum Toxin type A
Dysport
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Untreated chronic post-stroke spastic patients

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Goal Achievement Score (GAS).
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Change from baseline in pain according to Verbal Numerical Scale (VNS).
timeFrame: Baseline and 3 months
measure: Change from baseline in Modified Ashworth Scale (MAS) score
timeFrame: Baseline and 3 months
measure: Change from baseline in functional independence according to Barthel index score
timeFrame: Baseline and 3 months
measure: Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará
city: Florianópolis
country: Brazil
facility: Centro Catarinense de Reabilitação
city: Goiânia
country: Brazil
facility: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
city: Joinville
country: Brazil
facility: Clinica Neurológica e Neurocirúrgica de Joinville
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho (HUCFF)
city: São José do Rio Preto
country: Brazil
facility: Instituto de Reabilitação Lucy Montoro - FAMERP
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórida de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital São Paulo - UNIFESP
city: São Paulo
country: Brazil
facility: HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: