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NCT03623243 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
A Phase 3 study of Multiple Sclerosis and Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
- 20
- Study locations
NCT03623243: Completed Phase 3 study of Multiple Sclerosis and Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT03623243 is a Phase 3 study of Multiple Sclerosis and Relapsing Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 185 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03623243, a Phase 3 study of Multiple Sclerosis and Relapsing Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date
Conditions Studied
Interventions
- DRUG Siponimod
Study Locations (20)
Florida
- Novartis Investigative Site - Boca Raton
- Novartis Investigative Site - Bradenton
- MS & Neuromuscular Center of Excellence - Clearwater
- Novartis Investigative Site - Maitland
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Ocala
- Novartis Investigative Site - Oldsmar
- Novartis Investigative Site - Orlando
- Novartis Investigative Site - Ormond Beach
- Novartis Investigative Site - Sarasota
Alabama
- Novartis Investigative Site - Birmingham
- Novartis Investigative Site - Cullman
- Alabama Neurology Associates - Homewood
California
- Novartis Investigative Site - Fresno
- Novartis Investigative Site - Fullerton
- Novartis Investigative Site - Irvine
Colorado
- Novartis Investigative Site - Colorado Springs
- Novartis Investigative Site - Denver
- Novartis Investigative Site - Fort Collins
Arizona
- Novartis Investigative Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2022-07-06 |
| Phase | Phase 3 |
What the finished NCT03623243 record still lists
NCT03623243 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Siponimod is the first listed.
NCT03623243 names 20 study sites across 5 states, led by Florida, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT03623243 about?
NCT03623243 is a clinical study titled "Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients". To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
What is the current status of trial NCT03623243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2019-02-14. Estimated completion is 2022-07-06.
What conditions does trial NCT03623243 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Relapsing Multiple Sclerosis, Advancing Multiple Sclerosis.
What interventions are being tested in trial NCT03623243?
The interventions under investigation include: Siponimod (DRUG).
Who is sponsoring clinical trial NCT03623243?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03623243 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03623243's enrollment target sits among peer trials
185 81st of 315 higher than 235 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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