CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 259 enrolled
Drug / intervention
Discontinuation of disease modifying therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03073603
NCT03073603Phase 4Completed
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Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)

University of Colorado, Denver·interventional·Posted Mar 8, 2017·Updated Aug 16, 2023

In Brief

A Phase 4 clinical trial evaluating Discontinuation of disease modifying therapy and Standard of Care for Multiple Sclerosis. Completed, enrolled 259 participants across 19 sites.

Detailed Summary

Natural history research in Multiple Sclerosis (MS) suggests that risk of relapses and new Magnetic Resonance Imaging (MRI) changes diminish significantly as people age, especially in MS patients 55 or older. Thus, the need to continue MS medicines that reduce relapses and new MRI lesions may also decrease as people age, especially in those who have not had relapses or MRI scan changes for prolonged times. This study plans to learn more about the safety of stopping MS medication in this population, as compared to continuing on the medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, National Multiple Sclerosis Society, University of Alabama at Birmingham

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 8, 2017
Enrollment StartApr 20, 2017
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.3 years ago

Interventions

Discontinuation of disease modifying therapydrug

Participants who will discontinue their current MS drug. No other changes to their treatment occur.

Standard of Caredrug

Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include \~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease.