Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT03073603
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCOMS
Brief 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.
Detailed Description:
Participants will be randomized (1:1) to one of two groups. One group will stay on their current MS medication (Continue group), and one group will discontinue their medication (Discontinue group). They will also have some extra assessments done at their regular routine MS clinic appointment and every 6 months for the next 18-24 months. The following items will be done in addition to any assessments or procedures they are already having done as part of their clinical care:
* Questionnaires about the participant's quality of life including questions about health, mood, thinking, and social life
* Questionnaires about the participant's MS symptoms
* Test of the participant's attention, concentration, and thinking
* Test of the participant's physical symptoms
* In addition to any MRIs the participants may get as part of their routine care, they will also have an MRI 6 months from their enrollment into the study.
* Questionnaires about the participant's quality of life including questions about health, mood, thinking, and social life
* Questionnaires about the participant's MS symptoms
* Test of the participant's attention, concentration, and thinking
* Test of the participant's physical symptoms
* In addition to any MRIs the participants may get as part of their routine care, they will also have an MRI 6 months from their enrollment into the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: