The Canadian Institutes of Health Research (CIHR) has announced
the research team that will conduct a clinical trial to treat CCSVI
(chronic cerebrospinal venous insufficiency) in MS. The phase I/II clinical trial is designed to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. Participation in the trial is limited to Canadian residents.
Funding for the $6 million (Canadian dollars) study is a collaborative effort between CIHR, the MS Society of Canada and the provinces where the trial will take place.
The team leader, Dr. Anthony Traboulsee (University of British Columbia Hospital MS Clinic), who is an internationally recognized MS expert involved in the BC CCSVI Registry, has obtained required ethics approval from relevant institutional research ethics board(s). According to the CIHR, approximately 100 people with MS are expected to participate in the trial, to be conducted in British Columbia and Québec. Ethics approval is also being sought in Manitoba. Recruitment of participants will begin by November 1, 2012. Read more.
The National MS Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible. To build understanding of CCSVI, seven studies were launched on July 1, 2010 with a more than $ 2.4 million commitment from the MS Society of Canada and the U.S. National MS Society. Dr. Traboulsee is leader of one of the seven multi-disciplinary teams. Read the 2-year progress report
from the teams investigating CCSVI in MS.
“The National MS Society welcomes the announcement that a clinical trial regarding the treatment of CCSVI in MS has received required approvals,” said Dr. Timothy Coetzee, the Society’s Chief Research Officer. “We are pleased that our funded CCSVI researchers have advised CIHR on CCSVI and on elements of the design of the clinical trial. We look forward to reviewing the results of this and other studies as we formulate our next steps.”
In April 2012, the CIHR indicated that after a rigorous peer review process, a team had been chosen for the phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS, but did not reveal the identity of the team pending ethics approval.
The selection of the clinical trial research team follows the CIHR’s release of a Request for Proposals
that sought grant applications from researchers to conduct an early-phase clinical trial in Canada to test the ability of a surgical procedure called balloon venoplasty to improve blood drainage in individuals with MS who have been identified as having CCSVI.
There have been conflicting reports about whether and to what extent CCSVI impacts MS disease activity. Although some individuals who have MS have undergone this surgical procedure, there has not yet been a controlled trial to determine its effectiveness or safety. In May 2012, the U.S. FDA issued a safety communication about procedures to treat CCSVI and encouraging more research.
The CIHR has posted Frequently Asked Questions about the clinical trial, including information on how participants will be chosen. Read more