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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-005280-24-CZ (EUCTR) | 19/05/2015 | 24/11/2014 | Evaluate 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | Serbia;United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 2 | EUCTR2011-005280-24-NL (EUCTR) | 30/01/2013 | 19/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 3 | EUCTR2011-005280-24-PL (EUCTR) | 11/01/2013 | 11/12/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 4 | EUCTR2011-005280-24-GR (EUCTR) | 17/10/2012 | 24/09/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway;Japan | ||
| 5 | EUCTR2011-005280-24-BE (EUCTR) | 08/10/2012 | 04/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 6 | EUCTR2011-005280-24-GB (EUCTR) | 25/09/2012 | 09/08/2012 | Evaluate 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: 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 AG | NULL | Not 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): no | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 7 | EUCTR2011-005280-24-ES (EUCTR) | 19/09/2012 | 07/08/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinatingpolyradiculoneuropathy | 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] | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Norway;Germany;Japan | ||
| 8 | EUCTR2011-005280-24-IT (EUCTR) | 17/09/2012 | 13/09/2012 | Evaluate 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 9 | JPRN-JapicCTI-121961 | 01/9/2012 | 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) | 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. | NULL | 18 | BOTH | 156 | Phase 3 | NULL | |||
| 10 | EUCTR2011-005280-24-DE (EUCTR) | 29/08/2012 | 30/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan |