- Q: When will patients be contacted to participate?
A: We anticipate that screening will occur in early November or December 2012.
- Q: How can I participate?
A: There will be stringent enrollment criteria to ensure patient safety and scientific validity of the study. This may mean that some interested patients may not be eligible. Patients must have documented confirmation of the diagnosis of MS (either Relapsing Remitting, Secondary Progressive, or Primary Progressive).
Patients can only be enrolled through the trial sites
Patients must be a resident of the province of a trial site. Currently, out of province patients are not eligible for enrolment, but the study team is looking at expanding trial sites to other areas within Canada that have the necessary facilities and expertise.
Patients must live within a distance that will allow for reasonable travel to the trial site as the procedure involves surgical intervention and frequent follow up visits.
Patients who have had a CCSVI procedure are not eligible for this trial (please participate in the BC CCSVI registry).
Patients must be able to walk with or without an assistive device (such as a cane or walker) for a minimum of 20 meters.
Patients should not discontinue their current MS treatments.
Patients must be willing to remain in the study for two years.
- Q: How do I contact the study team?
A: Please email us at firstname.lastname@example.org. Due to the high level of interest it can take several weeks or longer before each email is answered. Emails will be answered in the order they are received. Please do not call the MS Clinic as you will be directed to this email and website.
- Q: What do I do if I am not selected?
A: There may be other research opportunities in MS that you can participant in. Please contact your local MS center or MS Society of Canada chapter for a list of ongoing research.
- Q: Will all participants have the liberation treatment?
A: Yes for all patients with confirmed evidence of CCSVI. However, at the beginning of the trial, half the patients will be randomly assigned (like flipping a coin) to venous dilation with a balloon and half will receive a sham (mock) treatment. After one year, patients will receive the other treatment.
- Q: How long will the study last?
A: Each patient will be followed for two years. However, the trial itself will last up to 4 years.
- Q: If I am selected for screening, does that mean I will be treated?
A: No. The screening process is to determine if you have evidence of CCSVI. If that is not detected, you will not proceed further in the study.
- Q: Why will only 100 patients be recruited?
A: Phase I/II clinical trials, which include a small group of patients, are conducted to determine the safety and efficacy of a new intervention without putting the life of patients at risk.
Complications related to the CCSVI treatments (i.e., ballooning and stents) offered abroad have been reported, and many national and international organizations advise MS patients against these treatments.
As an example, on May 10, 2012, the United States Food and Drug Administration issued an alert of the potential dangers of unproven treatment for multiple sclerosis and encouraged "rigourously--conducted, properly-targeted research to evaluate the relationship between CCSVI and MS".
In this context, scientific experts recommend that the safety and efficacy of the CCSVI procedure be proven before clinical trials on larger groups of patients are conducted.
- Q: How many centers in Canada will be involved?
A: Currently there are two participating sites. For more information on additional Canadian sites please visit the CIHR website www.cihr-irsc.gc.ca/e/42381.html
Thank you for your interest in the Canadian CCSVI Treatment Trial. Please refer to the website (www.vchri.ca/s/MS-CCSVI-NEWS.asp) for updates. Emails will be answered in the order that they are received. This may take several weeks due to the high volume.
For now please provide some basic details:
- First and Last name
- Date of Birth
- City and Province of Residence
- Date of MS onset or diagnosis
- What MS clinic do you attend?
- Have you had CCSVI or Liberation procedure done previously?