Patient trial of MS treatment given go-ahead
TORONTO—A long-awaited Canadian trial of a controversial experimental treatment for multiple sclerosis has been given the go-ahead and soon will begin recruiting patients, Health minister Leona Aglukkaq announced today.
Aglukkaq, in Halifax for a meeting with provincial and territorial health ministers, said about 100 MS patients will be enrolled in the trial to assess the safety and efficacy of the procedure to unblock narrowed neck veins.
Dr. Anthony Traboulsee, medical director of the UBC Hospital MS Clinic, will lead the $6-million study, which will be conducted initially in Vancouver and Montreal.
Medical and ethical approval also is being sought for parts of the trial to be conducted in Quebec City and Winnipeg, Traboulsee said today from Vancouver.
Participants will be split randomly into two groups: half the patients will get the treatment for CCSVI while the other half will get a sham procedure.
Then halfway through the trial, the two groups will switch, with the treated group getting the fake vascular surgery and the untreated group receiving the real thing.
None of the participants will know which treatment they got or when—a study design aimed at preventing subjective responses by patients when researchers evaluate effects of the treatment on their disease progression, Traboulsee said.
“This pan-Canadian controlled study will allow us to monitor MS patients over a two-year period, and obtain scientific evidence on the safety and efficacy of the CCSVI procedure in the long-term,” he explained.