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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 4,125 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01201356
The ClinicalTrials.gov registry entry for NCT01201356 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fingolimod is the first listed.
NCT01201356 reports 0 study locations.
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.
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