Trials / Completed
CompletedNCT03623243
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Detailed description
This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Siponimod | Siponimod 2mg tablets taken once daily |
Timeline
- Start date
- 2019-02-14
- Primary completion
- 2022-07-06
- Completion
- 2022-07-06
- First posted
- 2018-08-09
- Last updated
- 2024-06-20
- Results posted
- 2023-07-20
Locations
55 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03623243. Inclusion in this directory is not an endorsement.