Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
NCT ID: NCT01201356
Last Updated: 2021-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4125 participants
INTERVENTIONAL
2010-09-13
2018-10-19
Brief Summary
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Detailed Description
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* Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and
* Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fingolimod 0.5 mg/day
Open-label fingolimod 0.5 mg, taken orally once daily
Fingolimod
0.5 mg/day
Interventions
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Fingolimod
0.5 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
* Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c \> 8%.
* Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
* Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
* Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
* Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
* Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
* Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
* Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
* History or presence of a third degree AV block
* Proven history of sick sinus syndrome or sino-atrial heart block
* Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
* Any of the following pulmonary conditions during the previous fingolimod study:
* Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
* Active tuberculosis
* Alcohol abuse, chronic liver disease during the previous fingolimod study.
The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Cona, FE, Italy
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Foggia, FG, Italy
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Florence, FI, Italy
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Udine, UD, Italy
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Irbid, , Jordan
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, , Malaysia
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Breda, CK, Netherlands
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Amsterdam, , Netherlands
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Enschede, , Netherlands
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Stavanger, , Norway
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Unterhaching, , Germany
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Wendlingen, , Germany
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Wermsdorf, , Germany
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Wiesbaden, , Germany
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Wuppertal, , Germany
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Würzburg, , Germany
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Würzburg, , Germany
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Alexandroupoli, Evros, Greece
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Heraklion Crete, Greece, Greece
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Athens, GR, Greece
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Athens, GR, Greece
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Thessaloniki, GR, Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Guatemala City, , Guatemala
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Guatemala City, , Guatemala
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Budapest, HUN, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Dublin, , Ireland
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Dublin, , Ireland
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Ashkelon, , Israel
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Haifa, , Israel
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Ramat Gan, , Israel
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Sefad, , Israel
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Asti, AT, Italy
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Acquaviva delle Fonti, BA, Italy
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Montichiari, BS, Italy
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Cagliari, CA, Italy
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Chieti, CH, Italy
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Catania, CT, Italy
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Catania, CT, Italy
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Great Yarmouth, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Middlesbrough, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Northampton, , United Kingdom
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Nottingham, , United Kingdom
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Poole, , United Kingdom
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Swindon, , United Kingdom
Countries
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References
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Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-020515-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720D2399
Identifier Type: -
Identifier Source: org_study_id
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