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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390206
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date March 4, 2015
First Posted Date March 17, 2015
Last Update Posted Date October 2, 2017
Study Start Date June 2015
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2015)
Change in Goal Achievement Score (GAS). [ Time Frame: 3 and 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Untreated chronic post-stroke spastic patients
Condition Spasticity
Intervention Not Provided
Study Groups/Cohorts 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2017)
239
Original Estimated Enrollment
 (submitted: March 10, 2015)
244
Actual Study Completion Date August 28, 2017
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT02390206
Other Study ID Numbers A-38-52120-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Study Director Ipsen
PRS Account Ipsen
Verification Date September 2017