search
Back to results

Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Catheter venography with balloon venoplasty
Catheter venography with balloon venoplasty and balloon
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver Coastal Health - University of British Columbia Hospital
  • University of Manitoba Health Sciences Centre
  • Centre Hospitalier de l'Université de Montréal
  • CHU de Québec - Hôpital de l'Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Catheter Venography & Balloon Venoplasty

Catheter Venography Only

Arm Description

Patients will undergo catheter venography with balloon venoplasty procedure.

Patients will undergo catheter venography only.

Outcomes

Primary Outcome Measures

Adverse Events
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.

Secondary Outcome Measures

Clinical Outcome
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.
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.

Full Information

First Posted
May 13, 2013
Last Updated
April 12, 2018
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT01864941
Brief Title
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Official Title
Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter Venography & Balloon Venoplasty
Arm Type
Active Comparator
Arm Description
Patients will undergo catheter venography with balloon venoplasty procedure.
Arm Title
Catheter Venography Only
Arm Type
Sham Comparator
Arm Description
Patients will undergo catheter venography only.
Intervention Type
Procedure
Intervention Name(s)
Catheter venography with balloon venoplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Catheter venography with balloon venoplasty and balloon
Primary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Clinical Outcome
Description
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.
Time Frame
48 weeks
Title
Clinical Outcome
Description
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.
Time Frame
48 weeks
Title
Clinical Outcome
Description
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.
Time Frame
48 weeks
Title
Clinical Outcome
Description
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Traboulsee, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Vancouver Coastal Health - University of British Columbia Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
University of Manitoba Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHU de Québec - Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30266886
Citation
Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, Emond F, Gariepy JL, Bone JN, Siskin G, Klass D, Isserow S, Illes J, Sadovnick AD, Li DK. Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial. Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. Epub 2018 Sep 28.
Results Reference
derived

Learn more about this trial

Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

We'll reach out to this number within 24 hrs