Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
Completed · Phase 3
Conditions studied: Relapsing Forms of Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01201356
- Run by
- Novartis Pharmaceuticals
- People needed
- 4125
- Starts
- 2010-09-13
- Expected to finish
- 2018-10-19
- Last updated by the study team
- 2021-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Burlington, Vermont, United States
- Novartis Investigative Site — Charlottesville, Virginia, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
- Novartis Investigative Site — Villa Nueva, Mendoza Province, Argentina
- Novartis Investigative Site — Salta, Salta Province, Argentina
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
- Novartis Investigative Site — Córdoba, Argentina
- Novartis Investigative Site — Salta, Argentina
- Novartis Investigative Site — Camperdown, New South Wales, Australia
- Novartis Investigative Site — Chatswood, New South Wales, Australia
- Novartis Investigative Site — Kogarah, New South Wales, Australia
- Novartis Investigative Site — Liverpool, New South Wales, Australia
- Novartis Investigative Site — North Gosford, New South Wales, Australia
- Novartis Investigative Site — Woodville, South Australia, Australia
- Novartis Investigative Site — Box Hill, Victoria, Australia
- Novartis Investigative Site — Fitzroy, Victoria, Australia
- Novartis Investigative Site — Heidelberg, Victoria, Australia
- Novartis Investigative Site — Parkville, Victoria, Australia
- Novartis Investigative Site — Innsbruck, Tyrol, Austria
- Novartis Investigative Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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