Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis (NCT03540485) | Clinical Trial Compass
TerminatedPhase 1/2
Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis
Stopped: Early termination due to operational feasibility reasons, resulting from a slow recruitment rate and logistical and financial difficulties that prevent reaching the planned sample size within the study schedule.
Spain25 participantsStarted 2019-11-29
Plain-language summary
Phase I / II randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin administration combined with ocrelizumab in patients with Progressive Multiple Primary Sclerosis.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
Patients who come to the Multiple Sclerosis Unit of the Department of Neurology of the Virgen Macarena University Hospital (Seville) or Vithas Nisa Seville Hospital or Virgen del RocÃo University Hospital (Seville), and who meet the following criteria:
* Have progressive primary multiple sclerosis according to McDonald's diagnostic criteria modified in 2010.
* Age between 18 and 65 years old.
* Neurological impairment measured with the Expanded Disability Status Scale (EDSS) scale between 2 and 7 (both included, without disability or only clinical symptoms up to ambulatory capacity with bilateral support).
* Not having received any immunomodulatory, except for ocrelizumab in stable doses for at least 9 months before inclusion in this study, or immunosuppressive treatment (including cytostatic agents) during the 3 months prior to participation in the trial.
* If there is a possibility of pregnancy (in women of childbearing age (15 to 44 years)) or paternity, accept the use of a highly effective method of birth control recommended by the Clinical Trial Facilitation Group (CTFG) during the treatment phase of the trial..
* Not having consumed melatonin or other dietary supplements (antioxidants or vitamins (tripling the recommended daily doses) during the month prior to participation in the trial.
* Ability to give informed consent and comply with the visits scheduled in the study.
Exclusion Criteria:
* Alternative diagnosis that explains both the neurolog…
What they're measuring
1
Rates of neurological impairment
Timeframe: 2 years
2
Rates of disability
Timeframe: 2 years
Trial details
NCT IDNCT03540485
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla