The Canadian Institutes of Health Research (CIHR) will issue a call for proposals before the end of the year for a Phase I/II interventional trial on whether balloon venoplasty is a valid therapy for multiple sclerosis (MS).

Less than a year after concluding that Italian physician Dr. Paolo Zamboni’s controversial liberation therapy lacked scientific validity and posed risks to patients (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-3665),

CIHR’s Scientific Expert Working Group on Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis (CCSVI) has lined-up squarely behind the federal government’s decision to fund CCSVI trials.

Minister of Health Leona Aglukkaq said in late June that the federal government had decided to support phase 1 and phase 2 trials after hearing “moving” anecdotal evidence from MS patients and their families. Aglukkaq indicated that the CIHR working group was unanimously in favour of a trial (www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_87-eng.php). “I have asked CIHR to establish the terms of reference for this clinical trial. We are committed to launching an open and transparent call for applications as quickly as possible,” she said, adding that “it has been a moving experience to meet with and hear from so many MS patients and their families who have shown tremendous courage in the face of such a difficult illness. I wholeheartedly applaud those affected and their families who have to go through such difficult moments.”

Zamboni hypothesizes that multiple sclerosis is a vascular disorder caused by narrowing or blocking of internal jugular veins or the azygos vein, leading to accumulation of iron within the brain, and triggering the condition he calls CCSVI, which he treats by using angioplasty to eliminate the blockages.

CIHR indicated that the timing of the trial “is not determined at this time” (www.cihr-irsc.gc.ca/e/43953.html). “CIHR will be working over the fall with its Scientific Expert Working Group to develop the terms of reference for the trial and will then select, through a competitive and rigorous peer-review process, a research team to conduct the clinical trial.”

The Phase I/II interventional trail “will be designed to: (i) ensure standardized and accurate identification of MS patients meeting defined criteria for CCSVI; (ii) evaluate key measures that are sensitive to patient-reported outcomes of venoplasty; (iii) conduct the necessary safety evaluations of venoplasty for CCSVI including health risks such as blood clots; and (iv) evaluate whether the results of venoplasty are sustained over several months post-procedure,” CIHR said in a release (www.cihr-irsc.gc.ca/e/43952.html).

IHR also indicated that it will convene a “consensus workshop” for ultrasound imaging in hopes of developing a process to improve the comparability of seven North American studies of CCSVI now being funded by the MS Society of Canada and National MS Society (US). The workshop “will be held to share information and determine the best way of standardizing imaging of veins in the neck and brain. The standardized ultrasound methods optimized in this workshop will help ensure standardization of the seven ongoing studies and will contribute to the design of a Phase I/II interventional trial.” — Wayne Kondro, CMAJ 

http://www.cmaj.ca/content/183/12/E793.full?sid=3b2e1ec7-9804-41ed-a774-b216dec97baa

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