Other Clinical Trial - Metformin Add-on Clinical Study in Multiple

Status Recruiting

Clinical Trial Summary

This clinical trial aims to demonstrate that metformin can prevent clinical disability in patients with progressive MS by stopping or slowing down neurodegeneration by enhancing endogenous remyelination. Patients will continue their DMT treatment: metformin or placebo will be used as add-on study treatment.

Clinical Trial Description

Multiple Sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease leading to focal and diffuse damage of myelin sheath and axons in the central nervous system (CNS). Pathophysiologically, the adaptive and innate immune system are involved in the inflammatory process, while mitochondrial dysfunction, oxidative stress and failure of remyelination are important mechanisms leading to chronic neurodegeneration. Despite currently available disease modifying treatments (DMTs) that target the immune system, patients continue to accumulate disability. Unfortunately, no neuroprotective or remyelinating agents are available to treat progressive MS. Hence, drugs to tackle disease progression in MS represent a major unmet need. In this respect, metformin is a very interesting drug to investigate in MS patients as a neuroprotective and remyelinating therapy. Several preclinical studies in animal models of MS have shown that metformin has both anti-inflammatory, neuroprotective and remyelinating properties. A clinical study with metformin in a limited sample of MS patients did not demonstrate significant adverse events. The aim of this clinical trial is to provide evidence for the neuroprotective and remyelinating effects of metformin (I) in MS patients (P) via measurement of clinical and MRI outcome measures (O), via a multicentre randomized placebo-controlled (C) clinical trial. ;

Study Design

Related Conditions & MeSH terms

Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Nerve Degeneration
Primary Progressive Multiple Sclerosis
Sclerosis
Secondary-progressive Multiple Sclerosis

Clinical Trial Details

NCT number	NCT05893225
Study type	Interventional
Source	University Hospital, Antwerp
Contact	Clinical Trials Department of Neurology
Phone	+3238213000
Email	studies.neurologie@uza.be
Status	Recruiting
Phase	Phase 2
Start date	November 23, 2023
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05528666` - Risk Perception in Multiple Sclerosis
Completed	`NCT03608527` - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis	N/A
Recruiting	`NCT05532943` - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis	Phase 1/Phase 2
Completed	`NCT02486640` - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed	`NCT01324232` - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis	Phase 2
Completed	`NCT04546698` - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting	`NCT04380220` - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed	`NCT02835677` - Integrating Caregiver Support Into MS Care	N/A
Completed	`NCT03686826` - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting	`NCT05964829` - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis	N/A
Withdrawn	`NCT06021561` - Orofacial Pain in Multiple Sclerosis
Completed	`NCT03653585` - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting	`NCT04798651` - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis	N/A
Active, not recruiting	`NCT05054140` - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis	Phase 2
Completed	`NCT05447143` - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis	N/A
Recruiting	`NCT06195644` - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients	Phase 1
Completed	`NCT04147052` - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis	N/A
Completed	`NCT03591809` - Combined Exercise Training in Patients With Multiple Sclerosis	N/A
Completed	`NCT03594357` - Cognitive Functions in Patients With Multiple Sclerosis
Completed	`NCT02845635` - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms