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

NCT03540485 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Sclerosis, Multiple
  • Autoimmune Diseases of the Nervous System
  • Nervous System Diseases
  • Autoimmune Diseases

Interventions

DRUG

Melatonin

Daily administration of 100 mg of melatonin orally, for 24 months, single dose of melatonin between 10pm to 11pm

OTHER

Placebo

Daily administration of placebo orally, for 24 months between 10pm to 11pm

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Clara M Rosso Fernández, MD/PhD · Clinical Research and Clinical Trials Unit (Virgen del Rocío University Hospital, Seville)

  • Antonio Carrillo Vico, PhD · Institute of Biomedicine of Seville (IBiS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540485 on ClinicalTrials.gov