BIP_PHS Melatonin IIT
Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)
To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes.
Key Inclusion Criteria:
-Male and female subjects aged 18-65 with relapsing forms of MS who have been on a stable dose of dimethyl fumarate, fingolimod, or teriflunomide for 6 months or longer
Key Exclusion Criteria:
-Use of melatonin within 30 days of enrollment.
-The addition of any sleep aide or change in dose within 30 days of enrollment or during the trial.
-The addition or change in dose of Vitamin D within 30 days of enrollment or during the trial.
-Steroid therapy within 30 days of enrollment.
-The addition or change in dose of any stimulants, including but not limited to, amantadine, armodafinil, methylphenidate, or modafinil within 30 days of enrollment or during the trial.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Kyle E Smoot, M.D.
Providence Health & Services
- Providence St. Vincent Medical Center