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NCT01665144 · ClinicalTrials.gov registry record · Phase 3
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,651
- Enrollment target
NCT01665144: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01665144 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,651 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (114% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665144, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,651 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). 3-month confirmed disability progression is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increas
Interventions
- DRUG Placebo
- DRUG BAF312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,651 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 3 |
What the finished NCT01665144 record still lists
NCT01665144 is an interventional study that assigns participants to a tested intervention. Its 1,651 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (114% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01665144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01665144 about?
NCT01665144 is a clinical study titled "Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)". 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 ...
What is the current status of trial NCT01665144?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,651 participants. The study started on 2012-12-20. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT01665144?
The interventions under investigation include: Placebo (DRUG), BAF312 (DRUG).
Who is sponsoring clinical trial NCT01665144?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01665144's enrollment target sits among peer trials
1,651 139th of 2000 higher than 1,862 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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