An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00670449 |
|
Recruitment Status :
Completed
First Posted : May 1, 2008
Results First Posted : September 4, 2013
Last Update Posted : September 4, 2013
|
Sponsor:
Novartis
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: Fingolimod | Phase 2 |
A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.
The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 143 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Fingolimod 0.5 mg
Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
|
Drug: Fingolimod
Fingolimod was supplied in capsules.
Other Names:
|
|
Experimental: Fingolimod 1.25 mg
Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
|
Drug: Fingolimod
Fingolimod was supplied in capsules.
Other Names:
|
|
Experimental: Placebo-fingolimod
Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
|
Drug: Fingolimod
Fingolimod was supplied in capsules.
Other Names:
|
Primary Outcome Measures :
- Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions [ Time Frame: Months 6, 9, 12, 18, 24, 36, and 48 ]To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.
Secondary Outcome Measures :
- Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions [ Time Frame: Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years) ]To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of new or newly enlarged T2 weighted MRI lesions were counted and recorded. New lesions were identified by comparing each lesion with previous scans. Lesions expanding through several slices were counted as only 1 lesion.
- Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses [ Time Frame: Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years) ]The ARR was defined as the total number of relapses for all patients in the treatment arm / total number of days in the study for all patients in the treatment arm for the specific period of time × 365.25. General definition of relapse: Appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (< 37.5°C) or infection. A relapse was to be confirmed by a neurologist trained on the Expanded Disability Status Scale (EDSS). A relapse must be accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on 2 different Functional Systems (FS) of the EDSS or 2 points on 1 of the FS (excluding Bowel/Bladder or Cerebral FS).
- Percentage of Patients Relapse-free at the End of the Study [ Time Frame: Baseline to the end of the study (up to 4 years) ]Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients.
- Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment [ Time Frame: Baseline to the end of the study (up to 4 years) ]Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.
- Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score [ Time Frame: Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years) ]Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
- Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.
Exclusion Criteria:
- Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Information from the National Library of Medicine
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): NCT00670449
Locations
| Japan | |
| Novartis Investigative Site | |
| Chiba, Japan, 276-8524 | |
| Novartis Investigative Site | |
| Ehime, Japan, 791-0295 | |
| Novartis Investigative Site | |
| Fukuoka, Japan, 807-8555 | |
| Novartis Investigative Site | |
| Gunma, Japan, 371-8511 | |
| Novartis Investigative Site | |
| Hyogo, Japan, 650-0017 | |
| Novartis Investigative Site | |
| Ibaraki, Japan, 305-8576 | |
| Novartis Investigative Site | |
| Kanagawa, Japan, 259-1193 | |
| Novartis Investigative Site | |
| Kyoto, Japan, 604-8453 | |
| Novartis Investigative Site | |
| Kyoto, Japan, 616-8255 | |
| Novartis Investigative Site | |
| Morioka, Japan, 020-8505 | |
| Novartis Investigative Site | |
| Niigata, Japan, 951-8520 | |
| Novartis Investigative Site | |
| Osaka, Japan, 556-0016 | |
| Novartis Investigative Site | |
| Osaka, Japan, 589-8511 | |
| Novartis Investigative Site | |
| Osaka, Japan | |
| Novartis Investigative Site | |
| Sapporo, Japan, 060-8648 | |
| Novartis Investigative Site | |
| Tochigi, Japan, 329-0498 | |
| Novartis Investigative Site | |
| Tokyo, Japan, 113-8519 | |
| Novartis Investigative Site | |
| Tokyo, Japan, 145-0065 | |
| Novartis Investigative Site | |
| Tokyo, Japan, 162-8666 | |
| Novartis Investigative Site | |
| Wakayama, Japan, 641-8510 | |
Sponsors and Collaborators
Novartis
Mitsubishi Tanabe Pharma Corporation
Investigators
| Principal Investigator: | Novartis Pharmaceuticals, Japan | 81-3-3797-8748 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00670449 History of Changes |
| Other Study ID Numbers: |
CFTY720D1201E1 |
| First Posted: | May 1, 2008 Key Record Dates |
| Results First Posted: | September 4, 2013 |
| Last Update Posted: | September 4, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Novartis:
|
FTY720 multiple sclerosis MS |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis 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 |