Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I / II randomized, single-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin administration combined with ocrelizumab in patients with Progressive Multiple Primary Sclerosis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: Melatonin

Criteria

Inclusion Criteria:

Patients who come to the Multiple Sclerosis Unit of the Department of Neurology of the Virgen Macarena University Hospital (Seville, Spain) or Vithas Nisa Seville Hospital, 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 three 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 v.

• 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.