Ended Phase I and Phase II (Integrated)- First administration to humans Primary Progressive Multiple Sclerosis

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Melatonin Administration in Patients With Multiple Progressive Primary Sclerosis (MELATOMS-1)

EU CTIS ID: 2023-508457-10-00

What this study is testing

To assess the safety and efficacy of the combined administration of ocrelizumab and melatonin/placebo in patients with primary progressive multiple sclerosis

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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 Rocío University Hospital (Seville), AND who meet the following criteria: 1) Have progressive primary multiple sclerosis according to McDonald's diagnostic criteria modified in 2010; 2) Age between 18 and 65 years old; 3) 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); 4) 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; 5) 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; 6) 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; 7) Ability to give informed consent and comply with the visits scheduled in the study.

You likely can't join if

  • •Alternative diagnosis that explains both the neurological disability and the findings in nuclear magnetic resonance. •Clinically significant medical problems that, in the opinion of the investigators, may cause tissue damage in the central nervous system or limit its repair, or that may expose the patient to unjustified risks or damages, or cause the patient not to complete the study. •Clinical history of hypersensitivity reactions to melatonin. •Pregnancy or lactation, or planning to become pregnant or patients of childbearing age not subject to birth control methods (recommended by the Clinical Trial Facilitation Group (CTFG): http://www.hma.eu/fileadmin/dateien/Human_Medicines/ 01- About_HMA / Working_Groups / CTFG / 2014_09_HMA_CTFG_Contraception.pdf). •Abnormal results in basal blood tests, defined as: -Serum levels of alanine transaminase or aspartate transaminase greater than 1.5 times the upper limit of normal values. - Total leukocyte count less than 3,000 / mm3. - Platelet count less than 85,000 / mm3. - Serum creatinine level greater than 2.0 mg / dL or glomerular filtration rate less than 30 ml/min. •Neurological deterioration measured with the Expanded Disability Status Scale scale of less than 2 or greater than 7. •Be receiving any immunosuppressive therapy, except for ocrelizumab, including cytostatic agents.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.