RecruitingPhase 3NCT03653273

Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)

Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years


Sponsor

Rennes University Hospital

Enrollment

250 participants

Start Date

Jan 24, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Further controlled and randomized prospective studies in Multiple sclerosis, analyzing the potential impact of treatment discontinuation on disability progression, focal disease activity and quality of life are needed. The optimum patient age and duration of inactive SPMS before treatment withdrawal and the monitoring procedures also need to be specified, the ultimate goal being to provide evidence-based recommendations for clinical practice. Following the previous retrospective experience, we decided to drive a multicenter prospective study in France based on the hypothesis that stopping disease modifying therapy will not induce an increased risk of disability progression and relapse in selected SPMS patients (older patients without lesion activity) but will improve the quality of life and may reduce treatment-related costs.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether it is safe for people over 50 with secondary progressive multiple sclerosis (a form of MS where disability gradually worsens) to stop their disease-modifying medications, particularly when MS has been stable and not relapsing for several years. **You may be eligible if...** - You are over 50 years old - You have had a diagnosis of secondary progressive MS for at least 3 years - Your disability has been gradually worsening (not due to relapses) with an increase of at least 1 point on the disability scale since the progressive phase started - You have not had a relapse in the past 3 years - You are currently on a disease-modifying treatment for MS **You may NOT be eligible if...** - You have had a relapse in the past 3 years - You have active inflammation visible on recent MRI brain scans - Your MS is still in the relapsing-remitting phase - You have major health problems that would affect the study - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDMT withdrawal

Group 1 (DMT withdrawal) will not undergo any disease modifying treatments (DMT).

DRUGDMT continuation

Group 2 (DMT continuation) may undergo the DMT . The therapy continued in this research is the one previously established, at the same dose, not implying additional precautions for use.


Locations(27)

CHU Angers

Angers, France

CHU de Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CH de Chartres

Chartres, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

CHU Dijon

Dijon, France

CHU Grenoble

Grenoble, France

CH de Libourne

Libourne, France

CHU Lille

Lille, France

Hôpital Saint Vincent de Paul

Lille, France

CHU Montpellier

Montpellier, France

CHU Nancy

Nancy, France

CHU Nantes

Nantes, France

CHU Nice

Nice, France

CHU de Nîmes

Nîmes, France

CH Poissy

Poissy, France

CHU Poitiers

Poitiers, France

CH Quimper

Quimper, France

CHU Rennes

Rennes, France

CHU Strasbourg

Strasbourg, France

CH de Foch

Suresnes, France

CHU Tours

Tours, France

AP-HP (La Pitié Salpêtrière)

Paris, France

Hospices Civils Lyon

Lyon, France

AP-HM

Marseille, France

Fondation de Rothschild

Paris, France

View Full Details on ClinicalTrials.gov

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NCT03653273


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