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 [臨床試験数:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21

Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
43 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04281472
(ClinicalTrials.gov)
April 15, 202020/2/2020A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: efgartigimod PH20 SC in stage B;Other: placebo in stage BargenxNULLRecruiting18 YearsN/AAll400Phase 2United States;Bulgaria;Georgia;Germany;Hungary;Israel;Latvia;Poland;Russian Federation;Spain;Ukraine
2EUCTR2016-002411-17-GB
(EUCTR)
23/07/201914/08/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
34 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
3EUCTR2016-002411-17-NL
(EUCTR)
13/06/201902/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom
4EUCTR2016-002411-17-DE
(EUCTR)
23/05/201904/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
5EUCTR2016-002411-17-ES
(EUCTR)
09/05/201911/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-002411-17-BE
(EUCTR)
29/04/201908/02/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
7EUCTR2016-002411-17-DK
(EUCTR)
11/04/201920/02/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
34 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
8NCT03864185
(ClinicalTrials.gov)
March 28, 201919/2/2019The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 AutoantibodiesThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Biological: Rituximab (genetical recombination);Other: PlaceboNagoya UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Active, not recruiting12 YearsN/AAll25Phase 2Japan
9JPRN-UMIN000035753
2019/03/2802/02/2019The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial Chronic Inflammatory Demyelinating PolyneuropathyCIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.

CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Nagoya University HospitalZenyaku Kogyo Co., Ltd.Complete: follow-up continuing12years-oldNot applicableMale and Female25Phase 2Japan
10JPRN-jRCT2041180037
28/03/201931/01/2019RECIPE TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial Chronic Inflammatory Demyelinating Polyneuropathy
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Iijima MasahiroNULLNot Recruiting>= 12age oldNot applicableBoth25Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03861481
(ClinicalTrials.gov)
March 26, 20191/3/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Drug: Rozanolixizumab;Other: PlaceboUCB Biopharma S.P.R.L.NULLRecruiting18 YearsN/AAll34Phase 2United States;Belgium;Canada;Denmark;France;Germany;Netherlands;Spain;United Kingdom
12EUCTR2011-003448-28-PL
(EUCTR)
07/07/201506/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
13EUCTR2011-003448-28-EE
(EUCTR)
11/06/201514/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
14EUCTR2011-003448-28-LT
(EUCTR)
09/06/201521/04/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
15EUCTR2011-005280-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02372149
(ClinicalTrials.gov)
February 201512/2/2015IVIg for Demyelination in Diabetes MellitusTreatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot StudyPeripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating PolyneuropathyDrug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chlorideUniversity of TorontoUniversity Health Network, TorontoRecruiting18 YearsN/ABoth25Phase 4Canada
17EUCTR2011-005280-24-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
18EUCTR2011-005280-24-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
19EUCTR2011-005280-24-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
20EUCTR2011-005280-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-003448-28-BE
(EUCTR)
27/09/201202/04/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
22EUCTR2011-005280-24-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]
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
23EUCTR2011-005280-24-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
24EUCTR2011-005280-24-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
25JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-005280-24-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
27EUCTR2011-003448-28-IT
(EUCTR)
23/08/201229/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of
28EUCTR2011-003448-28-GB
(EUCTR)
23/05/201229/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
CSL Behring GmbHNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
29EUCTR2011-003448-28-AT
(EUCTR)
18/05/201216/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of
30EUCTR2011-003448-28-NL
(EUCTR)
11/05/201214/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-003448-28-CZ
(EUCTR)
09/05/201223/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
32EUCTR2011-003448-28-ES
(EUCTR)
24/04/201229/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Hungary;Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Finland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Korea, Republic of;Spain;United States
33EUCTR2011-003448-28-DE
(EUCTR)
20/04/201231/01/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
34EUCTR2011-003448-28-FI
(EUCTR)
05/04/201205/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Japan;United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands
35NCT01545076
(ClinicalTrials.gov)
March 20121/3/2012Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH StudyChronic Inflammatory Demyelinating Polyneuropathy;PolyradiculoneuropathyBiological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose)CSL BehringICON Clinical ResearchCompleted18 YearsN/AAll208Phase 3United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2009-017805-13-CZ
(EUCTR)
14/07/201122/04/2010PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders
Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2;Phase 3Czech Republic;Bulgaria
37EUCTR2009-017805-13-BG
(EUCTR)
27/01/201113/12/2010Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy.PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 14.0;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: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2/3India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria
38EUCTR2009-017805-13-RO
(EUCTR)
08/09/201015/07/2010PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy
Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2;Phase 3Czech Republic;Romania;Bulgaria
39EUCTR2009-013841-27-DK
(EUCTR)
17/12/200927/10/2009A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial Multifocal motor neuropathy
MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
40Denmark
40NCT00962429
(ClinicalTrials.gov)
February 200919/8/2009Lipoic Acid to Treat Chronic Inflammatory Demyelinating PolyneuropathyLipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot StudyCIDP;Chronic Inflammatory Demyelinating PolyneuropathyDrug: lipoic acidOregon Health and Science UniversityCollins Medical TrustCompleted18 Years80 YearsAll7Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00666263
(ClinicalTrials.gov)
August 200823/4/2008Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor NeuropathyA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor NeuropathyMultifocal Motor NeuropathyBiological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo)Baxalta now part of ShireNULLCompleted18 YearsN/AAll50Phase 3United States;Canada;Denmark;Netherlands;Poland
42NCT00220740
(ClinicalTrials.gov)
April 200413/9/2005Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.NULLCompleted18 YearsN/AAll117Phase 3United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro
43NCT00004772
(ClinicalTrials.gov)
September 199224/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune globulinNational Center for Research Resources (NCRR)Ohio State UniversityCompleted15 YearsN/ABoth90Phase 3NULL