Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Melatonin Administration in Patients With Multiple Progressive Primary Sclerosis (MELATOMS)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508457-10-00

Acronym

MELATOMS-1

Enrollment

Registered

2024-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Multiple Sclerosis

Brief summary

Disease progression: rates of neurological impairment (Kurtzke Expanded Disability Status Scale) and rates of disability (Multiple Sclerosis Functional Composite - MSFC scale).

Detailed description

Number of participants with treatment-related adverse events, Cerebral atrophy, Fatigue, Quality of life, Sleep disorders, Spasticity, Efficacy of neuroinflammation, Axonal damage, Oxidative stress, Impact on microbiota

Interventions

DRUGMELATONIN

DRUGExcipient No. 1 for Fagron capsules (200 milligrams)

DRUGComposition: 98.05% microcrystalline cellulose AND 1.95% colloidal silica.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease progression: rates of neurological impairment (Kurtzke Expanded Disability Status Scale) and rates of disability (Multiple Sclerosis Functional Composite - MSFC scale).	—

Secondary

Measure	Time frame
Number of participants with treatment-related adverse events, Cerebral atrophy, Fatigue, Quality of life, Sleep disorders, Spasticity, Efficacy of neuroinflammation, Axonal damage, Oxidative stress, Impact on microbiota	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026