Naltrexone Hydrochloride ( DrugBank: Naltrexone )


8 diseases
告示番号疾患名(ページ内リンク)臨床試験数
10シャルコー・マリー・トゥース病20
40高安動脈炎1
41巨細胞性動脈炎1
42結節性多発動脈炎1
43顕微鏡的多発血管炎1
44多発血管炎性肉芽腫症1
45好酸球性多発血管炎性肉芽腫症1
96クローン病1

10. シャルコー・マリー・トゥース病


臨床試験数 : 39 薬物数 : 44 - (DrugBank : 9) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004805-30-DK
(EUCTR)
31/01/202208/06/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy
2EUCTR2020-004805-30-NL
(EUCTR)
23/09/202127/05/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3France;United States;Canada;Spain;Belgium;Denmark;Israel;Germany;Netherlands;Italy
3EUCTR2020-004805-30-IT
(EUCTR)
19/05/202102/08/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) - na Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PXT3003
Product Code: [PXT3003]
INN or Proposed INN: BACLOFENE
INN or Proposed INN: NALTREXONE CLORIDRATO
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: SORBITOLO
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy
4EUCTR2020-004805-30-ES
(EUCTR)
04/05/202130/07/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3France;United States;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Germany;Italy
5EUCTR2020-004805-30-FR
(EUCTR)
04/05/202119/01/2022Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;France;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy
6NCT04762758
(ClinicalTrials.gov)
March 30, 202117/2/2021Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A PatientsA Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)Charcot-Marie-Tooth DiseaseDrug: (RS)-baclofen, naltrexone hydrochloride and D-sorbitol;Drug: PlaceboPharnext SAWorldwide Clinical TrialsRecruiting16 Years65 YearsAll350Phase 3United States;Belgium;Canada;Denmark;France;Germany;Israel;Italy;Netherlands;Spain
7EUCTR2015-002379-81-NL
(EUCTR)
08/01/201828/03/2017An International, multi-center, FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, open-label FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 1
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2 (equivalent to twice Dose 1)
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 3France;United States;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom
8EUCTR2015-002379-81-DE
(EUCTR)
15/08/201719/01/2017An International, multi-center, 9-month FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, open-label 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 2 (equivalent to twice Dose 1)
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
PharnextNULLNot RecruitingFemale: yes
Male: yes
290Phase 3France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom
9EUCTR2015-002379-81-GB
(EUCTR)
28/07/201712/06/2017An International, multi-center, FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, open-label FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 1
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2 (equivalent to twice Dose 1)
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
187Phase 3United States;France;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom
10EUCTR2015-002379-81-ES
(EUCTR)
25/05/201707/04/2017An International, multi-center, 9-month FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, double blind 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 19.1;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 1
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
PharnextNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom
11EUCTR2015-002379-81-BE
(EUCTR)
04/05/201721/02/2017An International, multi-center, 9-month FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, double blind 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 19.1;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 1
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
PharnextNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom
12EUCTR2015-002379-81-FR
(EUCTR)
26/01/201712/01/2017An International, multi-center, 9-month FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.International, multi-center, double blind 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A. Charcot-Marie-Tooth Disease type 1A
MedDRA version: 19.1;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 Dose 1
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Product Code: PXT3003 Dose 2
INN or Proposed INN: BACLOFEN
Other descriptive name: NA
INN or Proposed INN: NALTREXONE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
PharnextNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;France;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom
13EUCTR2015-002378-19-NL
(EUCTR)
21/04/201617/12/2015International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 monthsInternational, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXT SANULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Belgium;Spain;Germany;Netherlands;United Kingdom
14EUCTR2015-002378-19-DE
(EUCTR)
11/02/201628/09/2015International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 monthsInternational, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXTNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Belgium;Spain;Netherlands;Germany;United Kingdom
15EUCTR2015-002378-19-BE
(EUCTR)
18/01/201619/11/2015International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 monthsInternational, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXT SANULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Belgium;Netherlands;Germany;United Kingdom
16EUCTR2015-002378-19-ES
(EUCTR)
28/12/201530/10/2015International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 monthsInternational, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 18.1;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXTNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Netherlands;Germany;United Kingdom
17EUCTR2015-002378-19-FR
(EUCTR)
27/08/201527/07/2015 International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 18.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXTNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Belgium;Spain;Netherlands;Germany;United Kingdom
18EUCTR2015-002378-19-GB
(EUCTR)
16/12/2015 International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months International, multi-center, randomized, double-blind, placebo-controlled phase III study assessing in parallel groups the efficacy and safety of 2 doses of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A treated 15 months - PLEO-CMT Charcot-Marie-Tooth Disease - Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PXT3003 dose 1
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
Product Code: PXT3003 dose 2
INN or Proposed INN: RS-BACLOFEN
INN or Proposed INN: NALTREXONE HYDROCHLORIDE
Other descriptive name: NALTREXONE HYDROCHLORIDE
INN or Proposed INN: D-SORBITOL
Other descriptive name: D-SORBITOL
PHARNEXTNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Netherlands;Germany;United Kingdom
19EUCTR2020-004805-30-BE
(EUCTR)
04/03/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLNAFemale: yes
Male: yes
350Phase 3France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy
20EUCTR2020-004805-30-DE
(EUCTR)
05/02/2021Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patientsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) Charcot Marie Tooth Type 1A
MedDRA version: 20.0;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: PXT3003
INN or Proposed INN: BACLOFEN
Other descriptive name: (RS)-baclofen
INN or Proposed INN: NALTREXONE
Other descriptive name: naltrexone hydrochloride
INN or Proposed INN: Sorbitol
Other descriptive name: D-SORBITOL
Pharnext SANULLNAFemale: yes
Male: yes
350Phase 3France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy

40. 高安動脈炎


臨床試験数 : 25 薬物数 : 50 - (DrugBank : 21) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 114
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

41. 巨細胞性動脈炎


臨床試験数 : 128 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 124
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

42. 結節性多発動脈炎


臨床試験数 : 14 薬物数 : 27 - (DrugBank : 16) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 104
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

43. 顕微鏡的多発血管炎


臨床試験数 : 87 薬物数 : 84 - (DrugBank : 20) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 88
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

44. 多発血管炎性肉芽腫症


臨床試験数 : 92 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

45. 好酸球性多発血管炎性肉芽腫症


臨床試験数 : 28 薬物数 : 42 - (DrugBank : 18) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000852-32-NL
(EUCTR)
30/01/202008/10/2019A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Naltrexone hydrochlorideErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
122Phase 2Netherlands