Status:
COMPLETED
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Multiple Sclerosis Society of Canada
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- Previous venoplasty and/or stenting of extra cranial venous system
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01864941
Start Date
May 1 2013
End Date
August 1 2017
Last Update
April 17 2018
Active Locations (4)
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1
Vancouver Coastal Health - University of British Columbia Hospital
Vancouver, British Columbia, Canada, V6T 2B5
2
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
3
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
4
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4