Clinical trial of oral therapy: Fingolimod
study will involve 1,250 participants
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Medical Update Memo
August 22, 2006
Investigators are seeking participants with relapsing-remitting
MS for a large, international phase III clinical trial to evaluate
the effectiveness and safety of a potential oral MS therapy,
known as fingolimod or FTY720.
The study called FREEDOMS, (FTY720 Research Evaluation Daily
Oral efficacy in MS), will last 24 months and compare two dosage
levels of fingolimod to placebo. Approximately 1,250 people
with relapsing-remitting MS will participate at 125 centres
worldwide, including 10 in Canada. The study is sponsored by
Novartis.
The study will include people with relapsing-remitting MS
between the ages of 18 and 55 who have experienced at least
one relapse during the past year, or two relapses in the past
two years and meet the study eligibility criteria.
Results from a previous smaller study found after six months
of treatment, that fingolimod reduced the rate of clinical
relapses by more than 50 percent and reduced inflammatory
activity as measured by MRI by up to 80 percent compared to
placebo.
For more information about the study, please call 1-866-788-3930
or contact one of the participating Canadian clinical trial
sites listed below. You can also visit www.clinicaltrials.gov (U.S. government website; English only) or www.MSClinicalTrials.com (Novartis website; English only). Some of the study sites will
be using Internet-based recruitment, starting in September
2006. Information about the e-recruitment process will be provided
when it is available.
Canadian clinical trial sites
St. Michael's Hospital, Toronto, Dr. Paul O'Connor, 416-864-5830
University of British Columbia, Vancouver, Wendy Morrison,
Study Coordinator, 604-822-1756
Kingston General Hospital, MS Clinic, Kingston, Dr. Donald
G. Brunet or Vee McBride 613-548-2308
University of Saskatchewan, Regina, Felix Veloso, Principal
Investigator 306-525-3586
Dalhousie University, MS Research Unit, Halifax, Trudy
L. Campbell, 902-473-7947
University of Calgary, MS Clinical Research Program,
Calgary, Janet Moores, Study Coordinator, 403-944-1802
Nepean Medical Centre, Ottawa, Isabelle D. Bedirian,
Clinical Trials Coordinator, 613-224-1223
Health Sciences Centre, Winnipeg, Dr. Maria Melanson,
204-787-4778
ASK MS Information System Code: 1.4.1.75.a
National Research Department
National Marketing and Communications Department
Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or
recommend any specific product or therapy but provides
information to assist individuals in making their own decisions.
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