Melatonin in Patients With Multiple Sclerosis (MS).
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|ClinicalTrials.gov Identifier: NCT03498131|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Remitting Multiple Sclerosis||Drug: 3 mg Melatonin Drug: 5 mg Melatonin||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|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|
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
- 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
- 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.
- Serum melatonin level [ Time Frame: 3, 6, and 12 months ]Changes is morning blood levels of melatonin
- 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.
- 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.
- Relapse Rate [ Time Frame: 12 months ]Number of MS relapses during study
- 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.
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
|Contact: Tiffany Gervasi, MPH||503-216-1023||Tiffany.Gervasi@providence.org|
|Contact: Chiayi Chen, PhD.||(503) 216-1012||Chiayi.Chen@providence.org|
|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|
|Principal Investigator:||Kyle Smoot, MD||Providence Health & Services|