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NCT01216072 · ClinicalTrials.gov registry record · Phase 4
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,053
- Enrollment target
NCT01216072: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01216072 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,053 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216072, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.
Primary Outcome
The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as
Interventions
- DRUG Fingolimod
- DRUG Standard MS DMTs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01216072 record still lists
NCT01216072 is an interventional study that assigns participants to a tested intervention. Its 1,053 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 2 interventions - of which Fingolimod is the first listed.
NCT01216072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01216072 about?
NCT01216072 is a clinical study titled "A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis". The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fi...
What is the current status of trial NCT01216072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,053 participants. The study started on 2010-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01216072?
The interventions under investigation include: Fingolimod (DRUG), Standard MS DMTs (DRUG).
Who is sponsoring clinical trial NCT01216072?
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 NCT01216072's enrollment target sits among peer trials
1,053 66th of 2000 higher than 1,935 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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