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Melatonin in Patients With Multiple Sclerosis (MS).

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
3 mg Melatonin
5 mg Melatonin
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Melatonin, Supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence MS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 mg Melatonin

5 mg Melatonin

Arm Description

Subjects will receive 3 mg melatonin once a day.

Subjects will receive 5 mg melatonin once a day.

Outcomes

Primary Outcome Measures

Changes in urine melatonin levels
Changes in 24-hour urinary 6-sulfatoxymelatonin and serum morning Melatonin over time

Secondary Outcome Measures

Modified Fatigue Impact Scale (MFIS)
Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84. Higher scores indicate higher level of fatigue.
Serum melatonin level
Changes is morning blood levels of melatonin
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Changes in the MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36. Higher scores indicate greater impact of MS on QoL.
Pittsburgh Sleep Quality Index (PSQI)
Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality.
Relapse Rate
Number of MS relapses during study
Patient Determined Disease Steps - Performance Scale (PDDS-PS)
Changes in PDDS-PS: Patient Determined Disease Steps Performance Scales (PDDS-PS) is a PRO for MS disease status. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled.

Full Information

First Posted
April 6, 2018
Last Updated
August 2, 2023
Sponsor
Providence Health & Services
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1. Study Identification

Unique Protocol Identification Number
NCT03498131
Brief Title
Melatonin in Patients With Multiple Sclerosis (MS).
Official Title
Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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, teriflunomide, diroximel fumarate, siponimod, and ozanimod. 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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, MS, Melatonin, Supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned to receive melatonin at 3 milligrams (mg) once a day or 5mg once a day. The study drug will be taken at 21:00 each day ± 2 hours.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study is blinded to patients and providers.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 mg Melatonin
Arm Type
Experimental
Arm Description
Subjects will receive 3 mg melatonin once a day.
Arm Title
5 mg Melatonin
Arm Type
Experimental
Arm Description
Subjects will receive 5 mg melatonin once a day.
Intervention Type
Drug
Intervention Name(s)
3 mg Melatonin
Intervention Description
3 mg melatonin once each day
Intervention Type
Drug
Intervention Name(s)
5 mg Melatonin
Intervention Description
5 mg Melatonin once each day
Primary Outcome Measure Information:
Title
Changes in urine melatonin levels
Description
Changes in 24-hour urinary 6-sulfatoxymelatonin and serum morning Melatonin over time
Time Frame
3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale (MFIS)
Description
Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84. Higher scores indicate higher level of fatigue.
Time Frame
3, 6, and 12 months
Title
Serum melatonin level
Description
Changes is morning blood levels of melatonin
Time Frame
3, 6, and 12 months
Title
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
Changes in the MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36. Higher scores indicate greater impact of MS on QoL.
Time Frame
3, 6, and 12 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality.
Time Frame
3, 6, and 12 months
Title
Relapse Rate
Description
Number of MS relapses during study
Time Frame
12 months
Title
Patient Determined Disease Steps - Performance Scale (PDDS-PS)
Description
Changes in PDDS-PS: Patient Determined Disease Steps Performance Scales (PDDS-PS) is a PRO for MS disease status. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled.
Time Frame
3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Smoot, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence MS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35355991
Citation
Ghareghani M, Farhadi Z, Rivest S, Zibara K. PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis. Front Immunol. 2022 Mar 9;13:862316. doi: 10.3389/fimmu.2022.862316. eCollection 2022.
Results Reference
derived
Links:
URL
https://oregon.providence.org/our-services/p/providence-brain-and-spine-institute/
Description
Providence Brain and Spine Institute

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Melatonin in Patients With Multiple Sclerosis (MS).

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