Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/11/2019 |
| Start Date: | December 20, 2012 |
| End Date: | September 22, 2023 |
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment
duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
and efficacy (Extension Part).
duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
and efficacy (Extension Part).
Inclusion Criteria:
- Prior history of relapsing remitting MS
- SPMS defined as progressive increase of disability over at least 6 months
- EDSS score of 3.0 to 6.5
- No relapse of corticosteroid treatment within 3 months
Exclusion Criteria:
- Women of child bearing potential must use reliable forms of contraception.
- Diagnosis of Macular edema during screening period
- Any medically unstable condition determined by investigator.
- Unable to undergo MRI scans
- Hypersensitivity to any study drugs or drugs of similar class Other protocol defined
inclusion/exclusion may apply.
We found this trial at
77
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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