Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01497262 |
Recruitment Status
:
Completed
First Posted
: December 22, 2011
Results First Posted
: March 19, 2015
Last Update Posted
: March 19, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Fingolimod | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
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Drug: Fingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
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- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 28 weeks ]Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
- Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. [ Time Frame: 4 months ]The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with relapsing remitting Multiple Sclerosis
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Exclusion Criteria:
- Patients with MS other than relapsing remitting MS
- Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
-
Patients who have been treated with:
- systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
- immunosuppressive medications within 3 months prior to baseline;
- monoclonal antibodies within 3 months prior to baseline;
- cladribine, mitoxantrone or alemtuzumab at any time.
- Uncontrolled diabetes mellitus at screening
- Diagnosis of macular edema during Screening Phase
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- Patients who have received total lymphoid irradiation or bone marrow transplantation.
- Patients with certain cardiovascular conditions and/or findings in the screening ECG
- Patients with certain liver conditions
- Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497262
Argentina | |
Novartis Investigative Site | |
Caba, Buenos Aires, Argentina, 1425 | |
Novartis Investigative Site | |
Guaymallen, Mendoza, Argentina, M5507XAD | |
Novartis Investigative Site | |
San Miguel de Tucuman, Tucumán, Argentina, T4000DPB | |
Novartis Investigative Site | |
San Miguel de Tucumán, Tucumán, Argentina, 4000 | |
Novartis Investigative Site | |
Cordoba, Argentina, X5004CDT | |
Novartis Investigative Site | |
Salta, Argentina, A4400ANG | |
Novartis Investigative Site | |
Salta, Argentina, A4400BKZ | |
Brazil | |
Novartis Investigative Site | |
Rio de Janeiro, RJ, Brazil, 20270-004 | |
Novartis Investigative Site | |
Rio de Janeiro, RJ, Brazil, 21941-590 | |
Novartis Investigative Site | |
Porto Alegre, RS, Brazil, 90610-000 | |
Colombia | |
Novartis Investigative Site | |
Barranquilla, Atlantico, Colombia | |
Novartis Investigative Site | |
Bogotá, Cundinamarca, Colombia, 110111 | |
Novartis Investigative Site | |
Bogotá, Colombia, 00000 | |
Novartis Investigative Site | |
Bogotá, Colombia | |
Novartis Investigative Site | |
Cali, Colombia | |
Jordan | |
Novartis Investigative Site | |
Amman, Jordan, 11942 | |
Novartis Investigative Site | |
Irbid, Jordan, 22110 | |
Malaysia | |
Novartis Investigative Site | |
Kuala Lumpur, Malaysia, 50586 | |
Novartis Investigative Site | |
Kuala Lumpur, Malaysia, 59100 | |
Novartis Investigative Site | |
Penang, Malaysia, 10990 | |
Mexico | |
Novartis Investigative Site | |
Mexico, Distrito Federal, Mexico, 06700 | |
Novartis Investigative Site | |
México, Distrito Federal, Mexico, 10700 | |
Novartis Investigative Site | |
Monterrey, Nuevo León, Mexico, 64060 | |
Novartis Investigative Site | |
San Nicolas De Los Garza, Nuevo León, Mexico, 66480 | |
Novartis Investigative Site | |
San Luis Potosí, Mexico, 78240 | |
Panama | |
Novartis Investigative Site | |
Panama City, Panamá, Panama | |
Peru | |
Novartis Investigative Site | |
La Perla, Callao, Peru, 04 | |
Novartis Investigative Site | |
Jesus Maria, Lima, Peru, 11 | |
Novartis Investigative Site | |
San Isidro, Lima, Peru, 27 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01497262 History of Changes |
Other Study ID Numbers: |
CFTY720D2325 |
First Posted: | December 22, 2011 Key Record Dates |
Results First Posted: | March 19, 2015 |
Last Update Posted: | March 19, 2015 |
Last Verified: | March 2015 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis Relapsing-Remitting |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Fingolimod Hydrochloride Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |