Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

April 12, 2018 updated by: Anthony Traboulsee, University of British Columbia

Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overview of study objectives are:

  • To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
  • To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
  • To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Coastal Health - University of British Columbia Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal
      • Quebec City, Quebec, Canada, G1J 1Z4
        • CHU de Quebec - Hopital de l'Enfant-Jésus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
  • Age 18 to 65 years inclusive
  • Neurostatus (EDSS) score at screening from 0 to 6.5
  • Fulfill ultrasound criteria for CCSVI

Exclusion Criteria:

  • Previous venoplasty and/or stenting of extra cranial venous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Catheter Venography & Balloon Venoplasty
Patients will undergo catheter venography with balloon venoplasty procedure.
Procedure: Catheter venography with balloon venoplasty
All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.
Device: Catheter venography with balloon venoplasty and balloon
Sham Comparator: Catheter Venography Only
Patients will undergo catheter venography only.
Procedure: Catheter venography with balloon venoplasty
All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 48 weeks
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome
Time Frame: 48 weeks
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by patient reported quality of life, pain and fatigue scales 48 weeks after the procedure.
48 weeks
Clinical Outcome
Time Frame: 48 weeks
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.
48 weeks
Clinical Outcome
Time Frame: 48 weeks
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.
48 weeks
Clinical Outcome
Time Frame: 48 weeks
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Multiple Sclerosis Society of Canada

Investigators

  • Study Director: Anthony Traboulsee, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-01153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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