NCT02390206

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

March 4, 2015

Last Update Submit

September 29, 2017

Conditions

Spasticity

Keywords

StrokeSpasticityBotulinum Toxin type ADysport

Outcome Measures

Primary Outcomes (1)

  • Change in Goal Achievement Score (GAS).

    3 and 6 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Untreated chronic post-stroke spastic patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará

Belém, 66045-110, Brazil

Location

Centro Catarinense de Reabilitação

Florianópolis, 88025-301, Brazil

Location

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Goiânia, 74653-230, Brazil

Location

Clinica Neurológica e Neurocirúrgica de Joinville

Joinville, 89202-165, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, 14048-900, Brazil

Location

Hospital Universitário Clementino Fraga Filho (HUCFF)

Rio de Janeiro, 21941-913, Brazil

Location

Instituto de Reabilitação Lucy Montoro - FAMERP

São José do Rio Preto, 1591-240, Brazil

Location

Irmandade da Santa Casa de Misericórida de São Paulo

São Paulo, 01221-010, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, 01323-903, Brazil

Location

Hospital São Paulo - UNIFESP

São Paulo, 04024-002, Brazil

Location

HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Muscle SpasticityStroke

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ipsen Study Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 17, 2015

Study Start

June 1, 2015

Primary Completion

August 28, 2017

Study Completion

August 28, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

BR(11)