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

Phase 1/2 Terminated 25 enrolled Andalusian Public Foundation for Health Research in Seville

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2019-11-29
Primary completion: 2026-02-18
Completion: 2026-02-18

Publications

Bejarano I, Jimenez-Jorge S, Lobo-Acosta MA, Alvarez-Lopez AI, Rosso-Fernandez CM, Lopez-Ruiz R, Eichau S, Ruiz-Pena JL, Geniz MA, Ampuero J, Ponce-Espana E, Merino-Bohorquez V, Camean M, Garcia-Sanchez MI, Izquierdo G, Guerrero JM, Romero-Gomez M, Lardone PJ, Carrillo-Vico A. Hepatic Safety of Adjunctive High-Dose Melatonin in Participants Receiving Ocrelizumab for Primary Progressive Multiple Sclerosis: Liver Toxicity Findings from a Phase I/II Randomised Clinical Trial (MELATOMS-1). CNS Drugs. 2026 Apr;40(4):579-596. doi: 10.1007/s40263-025-01261-w. Epub 2026 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Melatonin	Small molecule	100 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications