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

Outcome

Outcome not reported

Stopped (Enrollment): “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.”

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