Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864941
• Other study ID #: H12-01153
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 13, 2013
• Last updated: April 12, 2018
• Start date: May 2013
• Est. completion date: August 1, 2017

Study information

• Verified date: April 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	CHU de Québec - Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Canada	Vancouver Coastal Health - University of British Columbia Hospital	Vancouver	British Columbia
Canada	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 weeks
Secondary	Clinical Outcome	To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.	48 weeks
Secondary	Clinical Outcome	To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.	48 weeks
Secondary	Clinical Outcome	To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.	48 weeks

External Links

•   Canadian Institutes of Health Research - CCSVI Trial News Release