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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod 0.5 mg | Experimental | Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study. |
|
| Fingolimod 1.25 mg | Experimental | Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study. |
|
| Placebo-fingolimod | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | Fingolimod was supplied in capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions | 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. | Months 6, 9, 12, 18, 24, 36, and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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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 | Chiba | 276-8524 | 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. | |
| 24475777 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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) |
| Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses | 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). | Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years) |
| Percentage of Patients Relapse-free at the End of the Study | Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients. | Baseline to the end of the study (up to 4 years) |
| Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment | 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. | Baseline to the end of the study (up to 4 years) |
| Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score | 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. | Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years) |
| 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 | Morioka | 020-8505 | Japan |
| Novartis Investigative Site | Niigata | 951-8520 | Japan |
| Novartis Investigative Site | Osaka | 556-0016 | Japan |
| Novartis Investigative Site | Osaka | 589-8511 | Japan |
| Novartis Investigative Site | Osaka | Japan |
| Novartis Investigative Site | Sapporo | 060-8648 | Japan |
| Novartis Investigative Site | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Tokyo | 113-8519 | Japan |
| Novartis Investigative Site | Tokyo | 145-0065 | Japan |
| Novartis Investigative Site | Tokyo | 162-8666 | Japan |
| Novartis Investigative Site | Wakayama | 641-8510 | Japan |
| Kira J, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Nagato K, Tsumiyama I, von Rosenstiel P, Zhang-Auberson L, Saida T. Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. BMC Neurol. 2014 Jan 29;14:21. doi: 10.1186/1471-2377-14-21. |
| FG002 | Placebo-fingolimod 0.5 mg | 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. |
| FG003 | Placebo-fingolimod 1.25 mg | 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. |
| Switched to 0.5mg (Open Label) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Placebo-fingolimod 0.5 mg | 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. |
| BG003 | Placebo-fingolimod 1.25 mg | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions | 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. | Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion) | Posted | Number | Percentage of patients | Months 6, 9, 12, 18, 24, 36, and 48 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions | 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. | Core full analysis set(FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. Study became open-label with all patients receiving FTY720 0.5 mg/day. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb-2010). (approximately 22 months before study completion) | Posted | Number | Percentage of patients | 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) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses | 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). | Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion) | Posted | Number | Relapses per year | Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Relapse-free at the End of the Study | Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients. | Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010).(approximately 22 months before study completion) | Posted | Number | 95% Confidence Interval | Percentage of patients | Baseline to the end of the study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment | 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. | Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion) | Posted | Number | 95% Confidence Interval | Percentage of patients | Baseline to the end of the study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score | 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. | Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. • The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion) | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years) |
|
Not provided
Extension safety population: All patients who received at least 1 dose of study drug in the extension study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 46 | 43 | 46 | ||
| EG001 | 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. | 8 | 47 | 42 | 47 | ||
| EG002 | Placebo-fingolimod 1.25 mg | 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. | 5 | 23 | 21 | 23 | ||
| EG003 | Placebo-fingolimod 0.5 mg | 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. | 1 | 27 | 25 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eyeball rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuromyelitis optica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Radiculitis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided
| Male |
|
|
| Month 12 (N=44, 42, 36) |
|
| Month 18 (N=42, 40, 37) |
|
| Month 24 (N=38, 39, 33) |
|
| Month 36 (N=25, 21, 22) |
|
| Month 48 (N=3, 4, 1) |
|
| OG002 |
| Placebo-fingolimod |
Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study. |
|
|
Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study. |
| OG002 | Placebo-fingolimod | Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study. |
|
|
|
|
| OG001 | 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. |
| OG002 | Placebo-fingolimod | Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study. |
|
|
| OG001 |
| 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. |
| OG002 | Placebo-fingolimod | Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study. |
|
|