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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTY720 0.5 mg | Experimental | FTY720 |
|
| FTY720 1.25 mg | Experimental | FTY720 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug | Administered orally once daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 | Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded. | Month 3 and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only) | A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals, Japan | +81 3 3797 8748 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Sapporo | Hokkaido | Japan | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28129749 | Derived | Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5. | |
| 22354739 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | FTY720 1.25 mg | Administered orally once daily for 6 months |
| FG001 | FTY720 0.5 mg | Administered orally once daily for 6 months |
| FG002 | Placebo | Administered orally once daily for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FTY720 1.25 mg | Administered orally once daily for 6 months |
| BG001 | FTY720 0.5 mg | Administered orally once daily for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 | Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded. | Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer. | Posted | Number | Participants | Month 3 and Month 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FTY720 1.25mg | Administered orally once daily for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Administered orally once daily for 6 months |
|
| up to Month 6 |
| Number of Patients Free of New or Newly Enlarged T2 Lesions | The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion. | up to Month 3 and up to Month 6 |
| Annualized Relapse Rate (ARR) at 6 Months | Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate. | 6 Months |
| Chiba |
| 276-8524 |
| Japan |
| Novartis Investigative Site | Ehime | 791-0295 | Japan |
| Novartis Investigative Site | Fukuoka | 807-8555 | Japan |
| Novartis Investigative Site | Gunma | 371-8511 | Japan |
| Novartis Investigative Site | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Ibaraki | 305-8576 | Japan |
| Novartis Investigative Site | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Kyoto | 604-8453 | Japan |
| Novartis Investigative Site | Kyoto | 616-8255 | Japan |
| Novartis Investigative Site | Niigata | 951-8520 | Japan |
| Novartis | Numakunai | 020-8505 | Japan |
| Novartis Investigative Site | Osaka | 556-0016 | Japan |
| Novartis Investigative Site | Osaka | 589-8511 | Japan |
| Novartis Investigative Site | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Tokyo | 145-0065 | Japan |
| Novartis Investigative Site | Tokyo | 162-8666 | Japan |
| Novartis Investigative Site | Wakayama | 641-8510 | Japan |
| Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21. |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Discontinued before initiating treatment |
|
| BG002 | Placebo | Administered orally once daily for 6 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | FTY720 0.5 mg | Administered orally once daily for 6 months |
| OG002 | Placebo | Administered orally once daily for 6 months |
|
|
| Secondary | Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only) | A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). | Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS. | Posted | Number | Participants | up to Month 6 |
|
|
|
| Secondary | Number of Patients Free of New or Newly Enlarged T2 Lesions | The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion. | Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer. | Posted | Number | Participants | up to Month 3 and up to Month 6 |
|
|
|
| Secondary | Annualized Relapse Rate (ARR) at 6 Months | Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate. | Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS. | Posted | Number | Relapses per year | 6 Months |
|
|
|
| 11 |
| 54 |
| 42 |
| 54 |
| EG001 | FTY720 0.5mg | Administered orally once daily for 6 months | 5 | 57 | 41 | 57 |
| EG002 | Placebo | Administered orally once daily for 6 months | 3 | 57 | 27 | 57 |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
|