Melatonin in Patients With Multiple Sclerosis (MS).
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/17/2018 |
| Start Date: | May 9, 2018 |
| End Date: | March 2022 |
| Contact: | Tiffany Gervasi, MPH |
| Email: | Tiffany.Gervasi@providence.org |
| Phone: | 503-216-1023 |
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.
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.
The primary objective of this study is to evaluate the change in 24 hour urinary
6-sulfatoxymelatonin (6SMT) collected for 24 hours in two twelve hour sessions. The secondary
objectives are to evaluate the change in serum morning melatonin level. In addition, quality
of life (QOL) measures will be assessed including the Modified Fatigue Impact Scale (MFIS),
Multiple Sclerosis Impact Scale (MSIS-29), and the Pittsburgh Sleep Quality Index (PSQI).
Clinical objectives include the number of relapses during the trial and a change in the
Patient Determined Disease Steps (PDDS) & Performance Scales (PS).
The pilot study is a one-year randomized, rater- and dose-blinded trial evaluating the
potential role of melatonin in subjects with relapsing multiple sclerosis who have been
taking a stable dose of an oral disease modifying therapy (DMT) for at least 6 months. The
oral DMTs include dimethyl fumarate, fingolimod, and teriflunomide. Thirty subjects with
relapsing forms of multiple sclerosis who meet all of the eligibility criteria will be
enrolled at Providence Neurological Specialties in Portland, Oregon.
6-sulfatoxymelatonin (6SMT) collected for 24 hours in two twelve hour sessions. The secondary
objectives are to evaluate the change in serum morning melatonin level. In addition, quality
of life (QOL) measures will be assessed including the Modified Fatigue Impact Scale (MFIS),
Multiple Sclerosis Impact Scale (MSIS-29), and the Pittsburgh Sleep Quality Index (PSQI).
Clinical objectives include the number of relapses during the trial and a change in the
Patient Determined Disease Steps (PDDS) & Performance Scales (PS).
The pilot study is a one-year randomized, rater- and dose-blinded trial evaluating the
potential role of melatonin in subjects with relapsing multiple sclerosis who have been
taking a stable dose of an oral disease modifying therapy (DMT) for at least 6 months. The
oral DMTs include dimethyl fumarate, fingolimod, and teriflunomide. Thirty subjects with
relapsing forms of multiple sclerosis who meet all of the eligibility criteria will be
enrolled at Providence Neurological Specialties in Portland, Oregon.
Inclusion Criteria:
- Male and female subjects with relapsing forms of MS who have been on a stable dose of
dimethyl fumarate, fingolimod, or teriflunomide for 6 months or longer
- Confirmed diagnosis of Relapsing MS
- Women of childbearing potential must employ proven methods to prevent pregnancy during
the course of the trial; the acceptable method will be left to the judgment of the
investigator
- Not pregnant or lactating
- No evidence of significant cognitive or psychiatric disorder
- Able to understand the purpose and risks of the study
- Must be willing to sign an informed consent and follow the protocol requirements
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
- Change in disease modifying therapy (DMT) during the trial
- Steroid therapy within 30 days of enrollment
- Use of anticoagulation at the time of enrollment and during the trial
- 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
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