SpasticityB-CAUSENCT02390206
Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients
An observational study of Spasticity, run by Ipsen at 11 sites in Brazil.
Trial summary
The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity
- Type of treatment
- Injection or infusion
- How many people
- 239 participants
- Where
- 11 sitesBrazil
- Study dates
- Jun 2015to 28 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Untreated chronic post-stroke spastic patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará
Belém, 66045-110
Centro Catarinense de Reabilitação
Florianópolis, 88025-301
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Goiânia, 74653-230
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, 89202-165
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, 14048-900
Hospital Universitário Clementino Fraga Filho (HUCFF)
Rio de Janeiro, 21941-913
Instituto de Reabilitação Lucy Montoro - FAMERP
São José do Rio Preto, 1591-240
Irmandade da Santa Casa de Misericórida de São Paulo
São Paulo, 01221-010
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-903
Hospital São Paulo - UNIFESP
São Paulo, 04024-002
HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação
São Paulo, 05403-900
About this study
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
The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.
Read the 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.
- Conditions
- Spasticity
- Keywords
- Stroke, Spasticity, Botulinum Toxin type A, Dysport
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goal Achievement Score (GAS).
Measured: 3 and 6 months
Secondary outcomes (4)
Change from baseline in pain according to Verbal Numerical Scale (VNS).
Measured: Baseline and 3 months
Change from baseline in Modified Ashworth Scale (MAS) score
Measured: Baseline and 3 months
Change from baseline in functional independence according to Barthel index score
Measured: Baseline and 3 months
Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390206
- Sponsor's protocol ID
- A-38-52120-202
- Acronym
- B-CAUSE
- Status last verified
- Sep 2017
- First submitted
- 4 Mar 2015
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02390206
- Acronym / sponsor ID
- B-CAUSE / A-38-52120-202
- Conditions
- Spasticity
- Keywords
- Stroke, Spasticity, Botulinum Toxin type A, Dysport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Untreated chronic post-stroke spastic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Goal Achievement Score (GAS).
Time frame: 3 and 6 months
4 secondary outcomes
Change from baseline in pain according to Verbal Numerical Scale (VNS).
Time frame: Baseline and 3 months
Change from baseline in Modified Ashworth Scale (MAS) score
Time frame: Baseline and 3 months
Change from baseline in functional independence according to Barthel index score
Time frame: Baseline and 3 months
Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Ipsen at 11 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Goal Achievement Score (GAS). (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.