13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
2 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2010-020515-37-DE
(EUCTR)
13/09/201009/07/2010Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Trade Name: Gilenya 0,5 mg Hartkapseln
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
5000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden
2EUCTR2007-002627-32-DE
(EUCTR)
26/05/2008A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosisA double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis Primary progressive multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Gilenya 0,5 mg Hartkapseln
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
970United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden