ARCHIVED – Frequently Asked Questions - Information on the Phase I/II Clinical Trial
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Q1: What is the treatment for CCSVI and is it safe?
A1: Chronic Cerebrospinal Venous Insufficiency (CCSVI) was coined by Dr. Zamboni in Italy as a potential cause of MS. Dr. Zamboni's theory proposed that MS patients have abnormal venous blood flow from the brain and spinal cord, caused by structural abnormalities in the azygous and internal jugular veins of the neck. The treatment he proposed involved opening narrowed veins through the insertion of a balloon inside the vessels, an intervention referred to as venous angioplasty.
There have been increasing reports of complications related to this procedure abroad, and many national and international MS Societies advise MS patients against these treatments until more research is conducted.
Q2: What is currently being done in Canada to evaluate the safety and efficacy of the procedure proposed by Dr. Zamboni?
A2: After carefully weighting all available scientific evidence, the CIHR Scientific Expert Working Group recommended in June 2011, that CIHR move cautiously towards supporting a small scale Phase I/II clinical trial. The Working Group felt that at this point, the only way to better define the safety and impact of venous angioplasty on the clinical outcomes and quality of life of MS patients was to conduct a well-designed intervention trial with appropriate stringent patient safety considerations factored in.
In June 2011, the Government of Canada announced the establishment of a Phase I/II clinical trial.
Q3: What is a Phase I/II clinical trial?
A3: In a Phase I trial, a small group of people is selected to evaluate the safety of an intervention. Phase II trials are performed on a larger group of patients and are designed to assess the efficacy of the intervention, as well as continue Phase I safety assessments in a larger group of people.
The number of patients to be included in this study is expected to be less than 100 individuals with MS.
Q4: How will the team of researchers be selected and when?
A4: The Request for Applications will be posted on CIHR's website on November 30, 2011.The deadline for receiving applications is the end of February 2012. The applications received will undergo rigorous review at the end of March 2012 by an international peer review panel. To be fundable, applications must meet international standards of research excellence which will be determined by the peer review panel. A successful team must also ensure that the research protocol is approved by their institutional ethics board. If more than one site is involved, institutional research ethics boards from each site must approve the protocol.
Q5: How can MS patients participate in the Phase I/II clinical trial?
A5: It is expected that a team of researchers selected to conduct the Phase I/II clinical trial would recruit patients once they have received approval on their research protocol by their Institutional Ethics Review Board (s). It is not possible to know at this time where the study will be conducted until the peer review panel has completed its work in March 2012 and necessary approval (s) obtained from ethics review board (s).