Evaluating melatonin's safety and effectiveness for treating 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

This study is testing if adding melatonin to the treatment with ocrelizumab can help people with progressive multiple sclerosis feel better and reduce their disability.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Academic / other)
• Drugs / interventions: ocrelizumab
• Locations: 3 sites (Seville and 2 other locations)
• Trial ID: NCT03540485 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Phase I/II randomized, double-blind, placebo-controlled study aimed at assessing the safety and efficacy of melatonin when combined with ocrelizumab in patients with progressive primary multiple sclerosis (PP-MS). The study focuses on patients aged 18 to 65 who have been diagnosed with PP-MS and have specific levels of neurological impairment. The researchers will evaluate the effects of daily melatonin administration alongside ocrelizumab to determine its potential benefits in reducing disability and improving patient outcomes. The trial is conducted at multiple hospitals in Seville, Spain.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of progressive primary multiple sclerosis and specific levels of neurological impairment.

Not a fit: Patients who have received immunomodulatory treatments other than ocrelizumab in the past nine months or have undergone immunosuppressive treatments in the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from progressive primary multiple sclerosis.

How similar studies have performed: While melatonin has shown promise in animal models and limited patient cases, this specific combination therapy is novel and has not been extensively tested in similar studies.

Eligibility criteria

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 Rocío 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 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)).
* 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.
* 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.

Where this trial is running

Seville and 2 other locations

• Virgen Macarena Hospital — Seville, Spain (Recruiting)
• Virgen del Rocio University Hospital — Seville, Spain (Recruiting)
• Hospital Vithas Nisa Sevilla — Seville, Spain (Recruiting)

Study contacts

• Principal investigator: Clara M Rosso Fernández, MD/PhD — Clinical Research and Clinical Trials Unit (Virgen del Rocío University Hospital, Seville)
• Study coordinator: Clara M Rosso Fernández, MD/PhD

Conditions Sclerosis, Multiple; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases