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Melatonin in Patients With Multiple Sclerosis (MS).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498131
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: 3 mg Melatonin Drug: 5 mg Melatonin Early Phase 1

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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study is blinded to patients and providers.
Primary Purpose: Treatment
Official Title: Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: 3 mg Melatonin
Subjects will receive 3 mg melatonin once a day.
Drug: 3 mg Melatonin
3 mg melatonin once each day

Experimental: 5 mg Melatonin
Subjects will receive 5 mg melatonin once a day.
Drug: 5 mg Melatonin
5 mg Melatonin once each day




Primary Outcome Measures :
  1. Changes in urine melatonin levels [ Time Frame: 3, 6, and 12 months ]
    Changes in 24-hour urinary 6-sulfatoxymelatonin and serum morning Melatonin over time


Secondary Outcome Measures :
  1. Modified Fatigue Impact Scale (MFIS) [ Time Frame: 3, 6, and 12 months ]
    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.

  2. Serum melatonin level [ Time Frame: 3, 6, and 12 months ]
    Changes is morning blood levels of melatonin

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

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

  5. Relapse Rate [ Time Frame: 12 months ]
    Number of MS relapses during study

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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498131


Contacts
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Contact: Tiffany Gervasi, MPH 503-216-1023 Tiffany.Gervasi@providence.org
Contact: Chiayi Chen, PhD. (503) 216-1012 Chiayi.Chen@providence.org

Locations
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United States, Oregon
Providence MS Center Recruiting
Portland, Oregon, United States, 97225
Contact: Tiffany Gervasi    503-216-1023    Tiffany.Gervasi@providence.org   
Contact: Chiayi Chen, RN, PhD    (503) 216-1012    Chiayi.Chen@providence.org   
Sub-Investigator: Stanley Cohan, MD, PhD         
Sub-Investigator: Kiren Kresa-Reahl, MD         
Principal Investigator: Kyle Smoot, MD         
Sponsors and Collaborators
Providence Health & Services
Investigators
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Principal Investigator: Kyle Smoot, MD Providence Health & Services
Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT03498131    
Other Study ID Numbers: 2017000005
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Providence Health & Services:
Multiple Sclerosis
MS
Melatonin
Supplement
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants