14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details


臨床試験数 : 167 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23

  
10 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2011-005280-24-CZ
(EUCTR)
19/05/201524/11/2014Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 17.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3Serbia;United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
2EUCTR2011-005280-24-NL
(EUCTR)
30/01/201319/07/2012Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
3EUCTR2011-005280-24-PL
(EUCTR)
11/01/201311/12/2012Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
4EUCTR2011-005280-24-GR
(EUCTR)
17/10/201224/09/2012Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 15.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway;Japan
5EUCTR2011-005280-24-BE
(EUCTR)
08/10/201204/07/2012Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
6EUCTR2011-005280-24-GB
(EUCTR)
25/09/201209/08/2012 Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
7EUCTR2011-005280-24-ES
(EUCTR)
19/09/201207/08/2012Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GILENYA 0,5 mg cápsulas duras
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: HIDROCLORURO DE FINGOLIMOD
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Norway;Germany;Japan
8EUCTR2011-005280-24-IT
(EUCTR)
17/09/201213/09/2012Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy.A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720I
INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan
9JPRN-JapicCTI-121961
01/9/2012A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Intervention name : FTY720
INN of the intervention : fingolimod
Dosage And administration of the intervention : oral daily, 0.5 mg
Control intervention name : placebo
Dosage And administration of the control intervention : oral daily
Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K.NULL18BOTH156Phase 3NULL
10EUCTR2011-005280-24-DE
(EUCTR)
29/08/201230/07/2012Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathyA double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 19.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720I
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 2;Phase 3United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan