10. シャルコー・マリー・トゥース病 Charcot-Marie-Tooth disease Clinical trials / Disease details
臨床試験数 : 41 / 薬物数 : 46 - (DrugBank : 9) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 15
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004805-30-DK (EUCTR) | 31/01/2022 | 08/06/2021 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy | ||
| 2 | EUCTR2020-004805-30-NL (EUCTR) | 23/09/2021 | 27/05/2021 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | France;United States;Canada;Spain;Belgium;Denmark;Israel;Germany;Netherlands;Italy | ||
| 3 | EUCTR2020-004805-30-FR (EUCTR) | 04/05/2021 | 19/01/2022 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy | ||
| 4 | EUCTR2020-004805-30-ES (EUCTR) | 04/05/2021 | 30/07/2021 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Germany;Italy | ||
| 5 | NCT04762758 (ClinicalTrials.gov) | March 30, 2021 | 17/2/2021 | Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients | A 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 Disease | Drug: (RS)-baclofen, naltrexone hydrochloride and D-sorbitol;Drug: Placebo | Pharnext SA | Worldwide Clinical Trials | Active, not recruiting | 16 Years | 65 Years | All | 350 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Israel;Italy;Spain;Netherlands |
| 6 | EUCTR2020-004805-30-BE (EUCTR) | 04/03/2021 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | NA | Female: yes Male: yes | 387 | Phase 3 | France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy | |||
| 7 | EUCTR2020-004805-30-DE (EUCTR) | 05/02/2021 | Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients | A 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 SA | NULL | NA | Female: yes Male: yes | 387 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Germany;Italy |