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NCT01201356 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,125
- Enrollment target
NCT01201356: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01201356 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 4,125 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (434% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01201356, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,125 participants
- Enrollment target
Study Summary
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
Primary Outcome
Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Interventions
- DRUG Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,125 participants |
| Start Date | 2010-09-13 |
| Est. Completion | 2018-10-19 |
| Phase | Phase 3 |
What the finished NCT01201356 record still lists
NCT01201356 is an interventional study that assigns participants to a tested intervention. Its 4,125 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 (434% higher).
The record links to 0 conditions, and to 1 intervention - of which Fingolimod is the first listed.
NCT01201356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01201356 about?
NCT01201356 is a clinical study titled "Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis". The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension...
What is the current status of trial NCT01201356?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,125 participants. The study started on 2010-09-13. Estimated completion is 2018-10-19.
What interventions are being tested in trial NCT01201356?
The interventions under investigation include: Fingolimod (DRUG).
Who is sponsoring clinical trial NCT01201356?
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 NCT01201356's enrollment target sits among peer trials
4,125 61st of 2000 higher than 1,940 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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