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Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497262
First received: December 5, 2011
Last updated: March 17, 2015
Last verified: March 2015
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Purpose
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
| Condition | Intervention | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: Fingolimod | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Enrollment: | 162 |
| Study Start Date: | February 2012 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
Drug: Fingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497262
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497262
Locations
| 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 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
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 |
| Study First Received: | December 5, 2011 |
| Results First Received: | February 26, 2015 |
| Last Updated: | March 17, 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 |
ClinicalTrials.gov processed this record on June 27, 2017