During clinical trials, people who have
multiple sclerosis (MS) participate in studies that
test new therapies for the disease. The therapies tested in clinical trials
have shown promise in laboratory and animal research, but they may not have
been shown to be safe and effective for humans yet. Each trial requires that a
person meet specific requirements (involving, for example, age, time since
diagnosis, and course of MS) in order to ensure that the results will be clear
enough to be useful.
Medicines being tested in clinical trials pass through four
Phase I: Testing for safety
Testing for effectiveness against the disease. This phase is usually limited to
less than 50 people.
Phase III: Comparing the medicine with a
placebo or an already approved therapy. Participants
are watched closely for side effects. This phase may involve hundreds of people
in several locations.
Phase IV: Further testing of approved
Call the National
Multiple Sclerosis Society (1-800-FIGHT-MS, or 1-800-344-4867) or the Brain
Resources and Information Network of the National Institute of Neurological
Disorders and Stroke (1-800-352-9424) for information on clinical trials. Or
visit the National Institutes of Health clinical trials website at
www.ClinicalTrials.gov. Discuss with your doctor, nurse, or therapist the
possibility of participating in a trial. Current clinical trials involve
testing new medicines, higher doses of existing medicines, and combination
How this information was developed to help you make better health decisions.