Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Advancing RMS Patients.



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:3/31/2019
Start Date:February 14, 2019
End Date:April 27, 2020
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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Exploring the Safety and Tolerability of Conversion From Oral or Injectable Disease Modifying Therapies to Dose-titrated Oral Siponimod in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study

To assess early phase safety and tolerability of converting patients from approved oral and
injectable RMS DMTs to siponimod. The results of this study will guide clinically relevant
decisions related to the transition from frequently used RMS DMTs to siponimod and provide
clinically relevant data on safety and tolerability for healthcare providers who are
considering converting patients from currently approved RMS DMT to siponimod.

This is a 6-month, open-label, multi-center, single arm design, including 300 advancing RMS
patients, evaluating overall safety and tolerability profile when acutely converting to
siponimod from oral or injectable RMS DMT.

Key Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.

2. Male or female aged 18 to 65 years (inclusive) at screening

3. Patients with advancing RMS as defined by the principal investigator

4. Prior history of relapsing MS (RMS), with or without progressive features, according
to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013)

5. EDSS score of >2.0 to 6.5 (inclusive)

6. Having been continuously treated with oral or injectable RMS DMTs

Key Exclusion criteria:

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.

2. Patients with any medically unstable condition as determine by the investigator.

3. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
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sites
Sunrise, Florida 33351
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Indian Land, South Carolina 29707
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Lexington, Kentucky 40509
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San Antonio, Texas 78207
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