Multiple Sclerosis is an inflammatory disorder in which the immune cells attack the myelin sheath of the nervous system. Due to loss of insulation, valuable neurological information is not properly integrated, leading to worsening physical as well as mental symptoms. The disease covers mostly a relapsing-remitting course, with the ultimate deterioration of both mental and physical systems in advanced stages, compromising the quality of life and overall survival.
Several experimental drugs are being tested across the world in an effort to devise successful treatment options that can slow the progression of the disease or facilitate the remyelination of nervous tissues. In this regard, a new novel therapy will be tested in a double-blind, placebo-controlled cross-over trial to assess the remyelination potential of clemastine.
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The Phase 2 study will test the tolerability, safety, and effectiveness of active remyelinating molecule in multiple sclerosis patients with the relapsing-remitting course of the illness. Clemastine has been approved by the FDA for the treatment of allergic rhinitis after the discovery of its role in the differentiation of oligodendrocytes. So far, it is still in experimental stages as a potential therapy for MS.
The phase 2 study will be held at the University of California, San Francisco, and will enroll approximately 50 patients. As part of the trial, study participants will be required to come to USCF at least 5 times within a 6-month study period. The patients will be enrolled after preliminary examination and assessment of eligibility criteria. Besides a baseline visit, the patients will be called for follow-up visits at 1, 3 and 5 months.
Patients will be randomly assigned toin the study group or placebo group for 3 months. During the study period, each study participant is required to take the pill by mouth twice a day. The study group will receive 3 months of active drug therapy followed by 2 months of placebo, and the control group will receive 3 months of placebo followed by 2 months of active group.
Investigators will assess the remyelination of neurological regions via MRI, electrophysiological studies and anterior visual pathway studies. The primary outcome measure of the study is set at the assessment of Full Field Visual Evoked Potential that is performed at each patient follow-up visit. Secondary outcomes are assessment of tolerability, effectiveness and safety besides, measurement of serum B12 levels, serum Triglyceride Level, serum creatinine levels, serum hCG levels and electrophysiological evidence of remyelination by series of tests. The study is expected to be completed by September of 2014.
The patients can continue their active MS disease modifying treatments as long as they don’t participate in any other interventional research program.