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"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03772717January 1, 202110/12/2018Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyneuropathyDevice: Vital EMS+;Drug: Standard of CareEmory UniversityGeorgia Institute of TechnologyNot yet recruiting5 Years21 YearsAll10N/AUnited States
2NCT04658472December 18, 20201/12/2020Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)A Phase 2, Multicenter, Open-label, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: BIVV020SanofiNULLNot yet recruiting18 YearsN/AAll90Phase 2NULL
3NCT04480450November 202016/7/2020Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II StudyRituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II StudyChronic Inflammatory Demyelinating PolyneuropathyDrug: RituximabUniversity of Kansas Medical CenterNULLNot yet recruiting18 YearsN/AAll48Phase 2NULL
4EUCTR2019-003107-35-NL25/09/202001/05/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Georgia;Bulgaria;Latvia;Germany;Netherlands;Japan
5EUCTR2019-003107-35-DK22/09/202012/08/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04280718September 18, 202020/2/2020A Study to Assess the Long-term 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)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: Efgartigimod PH20 SCargenxNULLRecruiting18 YearsN/AAll360Phase 2Georgia
7EUCTR2019-003107-35-BG04/09/202011/06/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
8EUCTR2019-003076-39-DK19/08/202023/06/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
9EUCTR2020-002438-34-DK19/08/202011/06/2020Fampridine for treatment of functional disability in patients with immune mediated polyneuropathyFampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10072650Term: CIDPSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampyra
INN or Proposed INN: FAMPRIDINE
Department of Neurology, Odense University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Denmark
10EUCTR2019-003107-35-BE04/08/202020/03/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-003107-35-DE15/07/202024/02/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Japan
12EUCTR2019-003107-35-PL09/07/202006/04/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
13EUCTR2019-003076-39-NL03/07/202025/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Czechia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Latvia;Netherlands;Germany;Japan
14EUCTR2019-003076-39-DE25/06/202003/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Japan
15EUCTR2019-003076-39-BG17/06/202024/04/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;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
16EUCTR2019-003107-35-GB11/06/202016/04/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2Serbia;United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
17EUCTR2018-004392-12-NL11/06/202009/09/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy
18NCT04589299June 4, 20209/9/2020Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating PolyneuropathyCIDP - Chronic Inflammatory Demyelinating PolyneuropathyBiological: ImmunoglobulinUniversity of AarhusRigshospitalet, Denmark;Aarhus University Hospital;Odense University Hospital;Aalborg University HospitalRecruiting18 YearsN/AAll60Phase 4Denmark
19EUCTR2019-003076-39-BE29/05/202012/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
20EUCTR2019-003076-39-ES25/05/202028/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;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
21EUCTR2019-003107-35-HU15/05/202025/03/2020A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+ Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
22EUCTR2019-003076-39-GB07/05/202006/03/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
23EUCTR2019-003076-39-PL04/05/202020/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Latvia;Germany;Japan
24EUCTR2018-004392-12-DE29/04/202010/04/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
25EUCTR2019-003076-39-HU27/04/202020/02/2020A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (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) - ADHERE Chronic Inflammatory Demyelinating Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Latvia;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04281472April 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
27EUCTR2018-004392-12-GB20/11/201901/04/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
28EUCTR2018-004392-12-DK29/10/201916/09/2019 A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) 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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
29EUCTR2018-004392-12-FR10/09/201913/05/2019 A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) 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]
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
34 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom
30NCT04051944August 21, 20198/8/2019A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating PolyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Drug: RozanolixizumabUCB Biopharma SRLNULLEnrolling by invitation18 YearsN/AAll34Phase 2United States;Belgium;France;Netherlands;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-004392-12-BE20/08/201923/05/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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 2France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom
32EUCTR2018-003592-34-DK02/08/201914/03/2019Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathySubcutaneous immunoglobulin in de-novo CIDP(Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy) - SIDEC Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Denmark
33EUCTR2018-004392-12-ES01/08/201911/06/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
34EUCTR2016-002411-17-GB23/07/201914/08/2019A 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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
35EUCTR2016-002411-17-NL13/06/201902/04/2019A 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: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-002411-17-DE23/05/201904/04/2019A 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: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
37EUCTR2016-002411-17-ES09/05/201911/04/2019A 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: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
38EUCTR2016-002411-17-BE29/04/201908/02/2019A 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: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
39EUCTR2016-002411-17-DK11/04/201920/02/2019A 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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
40EUCTR2017-002511-34-GB01/04/201908/11/2019Initial treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) - combined immunoglobulin and steroid treatment versus immunoglobulin treatment alone.Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP - OPTIC Trial Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: methylprednisolone
Product Name: methylprednisolone
Trade Name: sodium chloride 0.9%
Product Name: sodium chloride 0.9%
Academic Medical Centre, Amsterdam, NLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 3Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41JPRN-UMIN0000357532019/03/2802/02/2019The 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
42NCT03864185March 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
43JPRN-jRCT204118003728/03/201931/01/2019RECIPE 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 applicableBoth25Japan
44NCT03861481March 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
45NCT03684018February 28, 201924/9/2018Single vs. Multiple Privigen Dose Regimens in Pediatric CIDPRandomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDPPediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: IgPro10CSL BehringNULLRecruiting2 Years16 YearsAll30Phase 4United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03801135October 3, 20184/10/2018Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate AnticoagulationA Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors ReplacementHumoral Rejection;Guillain-Barre Syndrome;Miller Fisher Syndrome;CIDP;Good Pasture Syndrome;Hyperviscosity SyndromeDrug: Fibrinogen concentrate;Other: Fresh Frozen PlasmaUniversity Medical Centre LjubljanaNULLRecruiting18 YearsN/AAll20N/ASlovenia
47EUCTR2017-002511-34-NL26/09/201817/04/2018Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial)Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial) - OPTIC trial Chronic inflammatory demyelinating polyneuropathy (CIDP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Methylprednisolone (Solu-Medrol)
Product Name: Methylprednisolon (Solu-Medrol)
Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 56083
Academisch Medisch CentrumNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 3Netherlands
48EUCTR2017-005034-36-IT22/05/201804/11/2020Study evaluating the effect of rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)An Italian database-based randomized controlled trial with Rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - A randomized controlled trial of rituximab in CIDP (CIDPRIT) Chronic inflammatory demyelinating polyradiculoneuropathy
MedDRA version: 20.0Level: LLTClassification code 10072650Term: CIDPSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML
Product Name: Rituximab
Product Code: [Rituximab]
INN or Proposed INN: RITUXIMAB
Trade Name: TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE
Product Name: Paracetamolo
Product Code: [Paracetamolo]
INN or Proposed INN: PARACETAMOLO
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Metilprednisolone sodio succinato
Product Code: [Metilprednisolone sodio succinato]
INN or Proposed INN: METILPREDNISOLONE SODIO SUCCINATO
Trade Name: TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML
Product Name: Clorfenamina maleato
Product Code: [Clorfenamina maleato]
INN or Proposed INN: CLORFENAMINA MALEATO
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Italy
49NCT02638207September 27, 201716/12/2015Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) NeuropathyProspective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyChronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyDrug: NewGamOctapharmaNULLCompleted18 YearsN/AAll142Phase 3Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden
50EUCTR2017-002024-24-DK08/09/201719/06/2017Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathyRandomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gammanorm
Product Name: Gammanorm
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus Unversity HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2015-005443-14-BG07/09/201730/05/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
52EUCTR2015-005443-14-SE29/06/201707/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
53NCT03166527June 1, 20178/5/2017Panzyga in CIDP Administered at Different Infusion RatesProspective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion RatesChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Drug: Immune Globulin 10% Intravenous SolutionVera BrilNULLNot yet recruiting18 YearsN/AAll30Phase 3Canada
54EUCTR2015-005443-14-CZ01/06/201712/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
55EUCTR2015-005443-14-DK01/06/201706/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 19.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2015-005443-14-PL16/05/201713/05/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
57EUCTR2015-005443-14-HU12/05/201707/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 19.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
58EUCTR2015-005443-14-DE28/04/201705/04/2017 Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noHungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
59NCT02967679December 5, 20168/11/2016SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudySERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudyChronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type 1B;Anti-MAG NeuropathyDrug: MD1003MedDay Pharmaceuticals SANULLCompleted20 Years85 YearsAll15Phase 2France
60NCT02885259September 201625/1/2016HyQvia in Multifocal Motor NeuropathySubcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: rHuPH20UMC UtrechtNULLNot yet recruiting18 Years99 YearsBoth20N/ANetherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-005557-73-DE10/08/201608/07/2016An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
62EUCTR2013-005558-31-DE10/08/201608/07/2016Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
63EUCTR2015-000828-28-NL26/07/201630/11/2015Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hyqvia
Product Name: Hyqvia
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
64NCT02556437June 201618/9/2015Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: HyQvia;Drug: SubcuviaJohannes JakobsenBaxter Healthcare CorporationCompleted18 Years90 YearsAll18Phase 2Denmark
65EUCTR2015-003453-18-DK25/11/201523/09/2015Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyA Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy Multifocal Motor Neuropathy (MMN)
MedDRA version: 18.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02574962August 201530/8/2015Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating NeuropathyPilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating NeuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: H.P. Acthar® GelMamatha Pasnoor, MDMallinckrodtWithdrawn18 YearsN/ABoth0Phase 2United States
67EUCTR2013-005558-31-FR23/07/201526/06/2015Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
68EUCTR2011-003448-28-PL07/07/201506/05/2015Chronic 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: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
69EUCTR2011-003448-28-EE11/06/201514/05/2015Chronic 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: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
70EUCTR2011-003448-28-LT09/06/201521/04/2015Chronic 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: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-005280-24-CZ19/05/201524/11/2014Evaluate 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: 17.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
72EUCTR2012-001995-12-IT19/05/201513/03/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 15.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom;Italy
73EUCTR2013-004157-24-CZ12/03/201524/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
74NCT02414490March 201513/3/2015IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength MeasurementsIntravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)Chronic Inflammatory Demyelinating PolyneuropathyDrug: Intravenous ImmunoglobulinUniversity of MinnesotaBriovaRx Infusion Services;CSL BehringCompleted18 Years85 YearsAll30United States
75EUCTR2013-005558-31-ES18/02/201516/12/2014Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT02372149February 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
77EUCTR2013-005558-31-IT26/01/201520/05/2015Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: : immunoglobulina umana normale 10% per somministrazione endovenosa
Product Code: I10E
INN or Proposed INN: immunoglobulina umana normale per somministrazione endovenosa
Other descriptive name: IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;United Kingdom;Italy
78EUCTR2013-005558-31-GB08/01/201519/11/2014Extension of the international study on efficacy and safety of I10E in CIDP patients International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2 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] - Nervous System Diseases [C10]
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
79EUCTR2013-005557-73-ES03/12/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
80EUCTR2013-004157-24-NL02/12/201420/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2013-005557-73-GB21/10/201415/08/2014An international study on efficacy and safety of I10E in CIDP patients An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM 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] - Nervous System Diseases [C10]
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
82EUCTR2013-004157-24-IT01/10/201421/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy
83EUCTR2013-005557-73-IT30/09/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy
84EUCTR2013-005557-73-FR24/09/201426/06/2015An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom
85EUCTR2013-005363-52-NL10/09/201427/03/2014Intravenous immunoglobulin overtreatment in CIDPIntravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 51680
Department of Neurology, Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02465359September 201412/12/2014Subcutaneous Immunoglobulin for CIDPA Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: Immune Globulin Subcutaneous (Human)University of South FloridaCSL BehringUnknown status18 Years80 YearsAll20N/AUnited States
87JPRN-JapicCTI-14247204/8/201413/03/2014Phase 3 study of GGS in multifocal motor neuropathy (MMN)Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study) Multifocal motor neuropathy (MMN)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH5Phase 3Japan
88NCT02027701July 30, 20143/1/2014Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingBiological: IgPro20CSL BehringNULLCompleted18 YearsN/AAll82Phase 3United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland
89EUCTR2013-004157-24-DE05/06/201425/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
90EUCTR2013-004157-24-GB30/04/201418/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003 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
80 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2013-004157-24-ES23/04/201427/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan
92EUCTR2013-004157-24-FI04/04/201419/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
93JPRN-JapicCTI-14247110/3/201413/03/2014Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP)Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study) Chronic inflammatory demyelinating polyneuropathy(CIDP)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH30Phase 3Japan
94EUCTR2013-004988-32-NL22/01/201420/01/2014Pharmacokinetics of IVIg treatment in patients with CIDPRotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Kiovig
Product Name: Kiovig
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
95NCT02111590January 20149/4/2014Immunoglobulin Dosage and Administration Form in CIDP and MMNThe Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMNChronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic AnemiaDrug: ImmunoglobulinsRigshospitalet, DenmarkAarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H.Completed18 Years80 YearsBoth36N/ADenmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT01951924December 201320/9/2013LIME Study (LFB IVIg MMN Efficacy Study)A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportCompleted18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
97EUCTR2012-001995-12-GB01/08/201303/06/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 18.0 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Italy;United Kingdom
98EUCTR2012-001995-12-ES12/07/201312/07/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.0Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
99EUCTR2012-001995-12-FR03/07/201304/04/2014A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
100EUCTR2013-001428-20-DK06/06/201306/06/2013Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathyRandomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 16.0Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT01827072April 20131/4/2013Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.Multifocal Motor NeuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNULLCompleted20 Years100 YearsBoth13Phase 3Japan
102NCT01824251April 20131/4/2013Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.Chronic Inflammatory Demyelinating PolyneuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNULLCompleted20 Years100 YearsBoth49Phase 3Japan
103EUCTR2011-005280-24-NL30/01/201319/07/2012Evaluate 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: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
104EUCTR2011-005280-24-PL11/01/201311/12/2012Evaluate 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: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
105EUCTR2011-005280-24-GR17/10/201224/09/2012Evaluate 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: 15.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2011-005280-24-BE08/10/201204/07/2012Evaluate 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: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
107EUCTR2011-003448-28-BE27/09/201202/04/2012Chronic 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: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
108EUCTR2011-005280-24-GB25/09/201209/08/2012 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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan
109EUCTR2011-005280-24-ES19/09/201207/08/2012Evaluate 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: 14.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
110EUCTR2011-005280-24-IT17/09/201213/09/2012Evaluate 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: 14.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111JPRN-JapicCTI-12196101/9/2012A 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.NULL18BOTH156NULL
112EUCTR2011-005280-24-DE29/08/201230/07/2012Evaluate 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: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
113EUCTR2011-003448-28-IT23/08/201229/03/2012Chronic 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: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
114EUCTR2011-003448-28-GB23/05/201229/03/2012Chronic 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 Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
115EUCTR2011-003448-28-AT18/05/201216/03/2012Chronic 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: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2011-003448-28-NL11/05/201214/03/2012Chronic 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: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
117EUCTR2011-003448-28-CZ09/05/201223/02/2012Chronic 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: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
118EUCTR2011-003448-28-ES24/04/201229/02/2012Chronic 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: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
119EUCTR2011-003448-28-DE20/04/201231/01/2012Chronic 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: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
120EUCTR2011-003448-28-FI05/04/201205/03/2012Chronic 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: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT01545076March 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
122EUCTR2009-017805-13-CZ14/07/201122/04/2010PROSPECTIVE, 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: 14.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
123EUCTR2009-017805-13-BG27/01/201113/12/2010Study 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: 14.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
124EUCTR2009-017672-24-FI30/11/201010/09/2010This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP).A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Finland
125NCT01184846November 201018/8/2010Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating PolyneuropathyA Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyneuropathyBiological: 10% liquid formulation of human immunoglobulinCSL BehringNULLCompleted18 YearsN/AAll31Phase 3Belgium;Finland;France;Germany;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2009-017672-24-BE13/09/201007/07/2010A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 13.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Finland;Belgium
127EUCTR2009-017805-13-RO08/09/201015/07/2010PROSPECTIVE, 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: 12.1Level: LLTClassification code 10057645Term: 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
128EUCTR2009-013841-27-DK17/12/200927/10/2009A 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: 12.0Level: LLTClassification code 10065579Term: 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
129NCT00962429February 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
130EUCTR2008-005748-18-GB02/01/200912/12/2008SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDYSAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY Multifocal motor neuropathy
MedDRA version: 9.1Level: PTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
Greater Glasgow and Clyde NHS Board and The University Of GlasgowNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT00666263August 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
132NCT00716066June 200815/7/2008Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute EncephalitisBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow TransplantationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)RecruitingN/A71 YearsAll40Phase 2United States
133EUCTR2007-000710-37-GB10/04/200815/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGermany;Italy;United Kingdom
134EUCTR2007-000710-37-DE10/12/200710/09/2007A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1Level: LLTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
135NCT00701662November 200718/6/2008A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)Multifocal Motor Neuropathy (MMN)Biological: VivaglobinCSL BehringNULLCompleted18 YearsN/AAll8Phase 2Italy;Switzerland;United Kingdom;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2007-000710-37-IT04/10/200712/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - NDA multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.
MedDRA version: 9.1Level: LLTClassification code 10036105Term: Polyneuropathy
Trade Name: Vivaglobin
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
137EUCTR2005-001136-76-IT09/07/200707/09/2007Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDPDouble blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IGVENA*FL 200ML 10G+SET
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
KEDRIONNULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
138EUCTR2004-002783-24-GB25/05/200631/03/2006Prednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trialPrednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trial Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder. CIDP is characterised by motor and/or sensory symptoms and signs in more than one limb, developing over at least two months. The disease runs a progressive, relapsing-remitting or monophasic course. The diagnosis of CIDP is based on the clinical, electrophysiological, cerebrospinal fluid features and, to a limited degree, on histopathology.Product Name: dexamethasone
Product Code: dexamethasone
INN or Proposed INN: Dexamethasone
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
AMC Medical research BVNULLNot RecruitingFemale: yes
Male: yes
52United Kingdom
139NCT00268788August 200521/12/2005Subcutaneous Immunoglobulin Treatment for Multifocal Motor NeuropathyA Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: Subcutaneous immunoglobulin;Drug: Intravenous immunoglobulinUniversity of AarhusNULLCompleted18 Years80 YearsBoth10Phase 2Denmark
140NCT00278629February 21, 200516/1/2006Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating PolyneuropathyNon-myeloablative Autologous Hematopoietic Stem Cell Transplantation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II TrialChronic Inflammatory Demyelinating PolyneuropathyBiological: hematopoietic stem cell transplantationNorthwestern UniversityNULLCompleted18 Years65 YearsAll80Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT01349270June 20045/5/2011Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIgMulticentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow upDemyelinating PolyneuropathyDrug: Immunoglobulin perfusion;Drug: PrednisoneCentre Hospitalier Universitaire de Saint EtienneLaboratoire français de Fractionnement et de BiotechnologiesCompleted18 Years80 YearsBoth40Phase 3France
142NCT00220740April 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
143NCT01236456October 20035/11/2010High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyA Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: CyclophosphamideStony Brook UniversityNULLWithdrawn18 Years75 YearsBoth25Phase 2United States
144NCT00004772September 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
145NCT00001287December 19903/11/1999Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Demyelinating Diseases;ParaproteinemiasDrug: intravenous immunoglobulin (IVIg)National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth60Phase 2United States