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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623596
The ClinicalTrials.gov registry entry for NCT01623596 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 881 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 167-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (428% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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