Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments catheter venography with balloon venoplasty, catheter venography with balloon venoplasty and balloon
Phase phase 1/phase 2
Sponsor University of British Columbia
Collaborator Canadian Institutes of Health Research (CIHR)
Start date May 2013
End date September 2016
Trial size 100 participants
Trial identifier NCT01864941, H12-01153

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients will undergo catheter venography with balloon venoplasty 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.
catheter venography with balloon venoplasty and balloon
(Sham Comparator)
Patients will undergo catheter venography only.
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.

Primary Outcomes

Measure
Adverse Events
time frame: 48 weeks

Secondary Outcomes

Measure
Clinical Outcome
time frame: 48 weeks
Clinical Outcome
time frame: 48 weeks
Clinical Outcome
time frame: 48 weeks
Clinical Outcome
time frame: 48 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.