Saskatchewan is providing funding for some Saskatchewan MS patients to participate in a Liberation Therapy clinical trial in Albany, New York. The clinical trial will explore the effectiveness of angioplasty in relieving MS symptoms.

Eighty-six Saskatchewan volunteers who meet the research study's eligibility criteria are expected to be enrolled in the two-year clinical trial.

Approximately 670 applications were received prior to the February 24, 2012 deadline.
Applicants will be contacted in the order their names are randomly selected. It is expected to take several months to contact, screen and medically assess enough patients to fill all available spaces in the study.

VIDEO: Health Minister McMorris describes the process for Saskatchewan people with MS to apply for inclusion in the clinical trial. January 12, Regina. (3:24)

PHOTO, RIGHT: Multiple sclerosis patient advocate Michelle Walsh spoke at the January 12 announcement at Regina's Wascana Rehabilitation Centre.

What is a clinical trial?
A clinical trial is a set of procedures used in medical research to safely collect data about the effectiveness of a procedure, drug, device or therapy. Patients are screened before becoming involved and are carefully monitored throughout the process.  

Can I still apply to participate in the Liberation Therapy clinical trial?
No. Applications closed on February 24, 2012.

How will patients be chosen?
Applications will be randomly selected so that everyone who applies has a fair and equal chance to participate. Those selected will be screened to ensure they are eligible.

What are the eligibility criteria?
To be enrolled in the study, volunteers must:

• be between the ages of 18 and 60
• be a resident of Saskatchewan
• agree to comply with the research protocols
• be able to travel between Canada and the United States
• not be pregnant, or planning to become pregnant within six months of entering the research study
• not had any changes in their drug regimen for MS in the six months prior to entering the research study
• not have a known allergy to nickel, iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated

Volunteers must also meet specific medical criteria, which will be assessed and confirmed by a physician during a detailed screening process.

Why can't people over age 60 be involved in the research?
The age restrictions for the study were set by the research team in Albany, New York. The researchers had a number of reasons for this limitation, to protect the integrity of the research results. One compelling reason for limiting the study to people under age 60 is that many patients over that age require changes in their medication regimen; that kind of situation could undermine the scientific value of the research findings. A sound scientific process will help patients and the healthcare system find out whether this treatment is a viable option for people who have multiple sclerosis.

How will I know if I have been selected or not?
Only those who are randomly selected will be contacted. Ideally, all patients to be enrolled in the study will be contacted within a few months. However, if some patients are screened out later in the process, others would need to be randomly selected from the remaining applications, so it could take several months to complete the process. Once the available slots have been filled, a public announcement will be made and all remaining applicants will be notified by e-mail.

How many patients will be selected?
The research group expects to accept 86 Saskatchewan patients. We may have to send about 100 people to Albany, since some are likely to be screened out further at that point.

Will Saskatchewan patients have to travel to the United States?
Yes. Patients selected will spend a few days at the Albany Medical Centre in Albany, New York.

Will every patient who goes to Albany actually have the Liberation Therapy procedure?
No. The clinical trial is a "double blind" study, meaning half of the patients will receive the procedure and half will not. Patients will not know until the study is over who has actually had the Liberation Therapy treatment.

How long will the research take?
Patients will be monitored for two years following enrollment in the clinical trial. During that period, they will be required to have regular follow up appointments with a neurologist in Regina.

Will it cost patients anything to participate?
No. The Saskatchewan government has made a commitment to pay for patient travel expenses related to the research.

Will patients be able to take someone with them to Albany?
Each patient will be able to take one support person. Airfare will be covered for a support person accompanying a patient. One hotel room will be covered per patient. A support person could arrange an additional hotel room at their own expense. 

Where can I get more information about the trial?
Call 1-800-667-7766 (toll-free in Saskatchewan) or 306-787-0146 for more information.