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NCT01623596 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.
A Phase 4 study of Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 881
- Enrollment target
- 20
- Study locations
NCT01623596: Completed Phase 4 study of Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT01623596 is a Phase 4 study of Relapsing Remitting Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 881 participants, above the 167-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (428% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623596, a Phase 4 study of Relapsing Remitting Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 881 participants
- Enrollment target
- 20
- Study locations
Study Summary
A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.
Primary Outcome
Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)
Conditions Studied
Interventions
- DRUG Fingolimod
- DRUG Disease Modifying therapy
Study Locations (20)
Colorado
- Novartis Investigative Site - Basalt
- Novartis Investigative Site - Boulder
- Novartis Investigative Site - Denver
- Novartis Investigative Site - Denver
- Novartis Investigative Site - Fort Collins
California
- Novartis Investigative Site - Fullerton
- Novartis Investigative Site - Oceanside
- Novartis Investigative Site - San Francisco
- Novartis Investigative Site - Walnut Creek
Arizona
- Novartis Investigative Site - Phoenix
- Novartis Investigative Site - Sun City
- Novartis Investigative Site - Tucson
Florida
- Novartis Investigative Site - Atlantis
- Novartis Investigative Site - Bradenton
- Novartis Investigative Site - Delray Beach
Connecticut
- Novartis Investigative Site - Fairfield
- Novartis Investigative Site - New London
Alabama
- Novartis Investigative Site - Cullman
Arkansas
- Novartis Investigative Site - Sherwood
Delaware
- Novartis Investigative Site - Dover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 881 participants |
| Start Date | 2012-06-08 |
| Est. Completion | 2015-07-13 |
| Phase | Phase 4 |
What the finished NCT01623596 record still lists
NCT01623596 is an interventional study that assigns participants to a tested intervention. The registered 881 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (428% higher).
The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Fingolimod is the first listed.
NCT01623596 names 20 study sites across 8 states, led by Colorado, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01623596 about?
NCT01623596 is a clinical study titled "Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.". A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able ...
What is the current status of trial NCT01623596?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 881 participants. The study started on 2012-06-08. Estimated completion is 2015-07-13.
What conditions does trial NCT01623596 study?
This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT01623596?
The interventions under investigation include: Fingolimod (DRUG), Disease Modifying therapy (DRUG).
Who is sponsoring clinical trial NCT01623596?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01623596 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Remitting Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01623596's enrollment target sits among peer trials
881 2nd of 25 the highest of 25 other Relapsing Remitting Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Remitting Multiple Sclerosis 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.
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