NCT01864941

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started May 2013

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

4.3 years

First QC Date

May 13, 2013

Last Update Submit

April 12, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMSCCSVIZambonicatheter venographyballoon angioplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Secondary Outcomes (4)

  • Clinical Outcome

    48 weeks

  • Clinical Outcome

    48 weeks

  • Clinical Outcome

    48 weeks

  • Clinical Outcome

    48 weeks

Study Arms (2)

Catheter Venography & Balloon Venoplasty

ACTIVE COMPARATOR

Patients will undergo catheter venography with balloon venoplasty procedure.

Procedure: Catheter venography with balloon venoplastyDevice: Catheter venography with balloon venoplasty and balloon

Catheter Venography Only

SHAM COMPARATOR

Patients will undergo catheter venography only.

Procedure: Catheter venography with balloon venoplasty

Interventions

Catheter venography with balloon venoplastyPROCEDURE

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.

Catheter Venography & Balloon VenoplastyCatheter Venography Only
Catheter venography with balloon venoplasty and balloonDEVICE
Catheter Venography & Balloon Venoplasty

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vancouver Coastal Health - University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30266886DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anthony Traboulsee, MD

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 30, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

CA(4)