Melatonin in Patients With Multiple Sclerosis (MS).

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT03498131
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Providence Health & Services
• Public title: Melatonin in Patients With Multiple Sclerosis (MS).
• Scientific title: Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)
• Date of first enrolment: May 9, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03498131
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Kyle Smoot, MD
• Affiliation: Providence Health & Services

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects with relapsing forms of MS who have been on a stable dose of
dimethyl fumarate, fingolimod, teriflunomide, diroximel fumarate, siponimod, or
ozanimod 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 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 of an antidepressant is not allowed during the study period; if on an
antidepressant at screening, the dose must be stable 30 days prior to enrollment and
dose changes are prohibited during the study

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: 3 mg Melatonin

Drug: 5 mg Melatonin

Primary Outcome(s)

Changes in urine melatonin levels [Time Frame: 3, 6, and 12 months]

Secondary Outcome(s)

Patient Determined Disease Steps - Performance Scale (PDDS-PS) [Time Frame: 3, 6, and 12 months]

Serum melatonin level [Time Frame: 3, 6, and 12 months]

Modified Fatigue Impact Scale (MFIS) [Time Frame: 3, 6, and 12 months]

Multiple Sclerosis Impact Scale-29 (MSIS-29) [Time Frame: 3, 6, and 12 months]

Pittsburgh Sleep Quality Index (PSQI) [Time Frame: 3, 6, and 12 months]

Relapse Rate [Time Frame: 12 months]

Secondary ID(s)

2017000005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors