NALTREXONE HYDROCHLORIDE ( DrugBank: Naltrexone )
8 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 10 | Charcot-Marie-Tooth disease | 20 |
| 40 | Takayasu arteritis | 1 |
| 41 | Giant cell arteritis | 1 |
| 42 | Polyarteritis nodosa | 1 |
| 43 | Microscopic polyangiitis | 1 |
| 44 | Wegener granulomatosis | 1 |
| 45 | Eosinophilic granulomatosis with Polyangiitis | 1 |
| 96 | Crohn disease | 1 |
10. Charcot-Marie-Tooth disease
Clinical trials : 39 / Drugs : 44 - (DrugBank : 9) / Drug target genes : 11 - Drug target pathways : 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-IT (EUCTR) | 19/05/2021 | 02/08/2021 | 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) - 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 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 | ||
| 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 | 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 | ||
| 6 | 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 | Recruiting | 16 Years | 65 Years | All | 350 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Israel;Italy;Netherlands;Spain |
| 7 | EUCTR2015-002379-81-NL (EUCTR) | 08/01/2018 | 28/03/2017 | An 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 3 | France;United States;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom | ||
| 8 | EUCTR2015-002379-81-DE (EUCTR) | 15/08/2017 | 19/01/2017 | An 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 | Pharnext | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 3 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 9 | EUCTR2015-002379-81-GB (EUCTR) | 28/07/2017 | 12/06/2017 | An 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 187 | Phase 3 | United States;France;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom | ||
| 10 | EUCTR2015-002379-81-ES (EUCTR) | 25/05/2017 | 07/04/2017 | An 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 | Pharnext | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 11 | EUCTR2015-002379-81-BE (EUCTR) | 04/05/2017 | 21/02/2017 | An 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 | Pharnext | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 12 | EUCTR2015-002379-81-FR (EUCTR) | 26/01/2017 | 12/01/2017 | An 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 | Pharnext | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;France;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 13 | EUCTR2015-002378-19-NL (EUCTR) | 21/04/2016 | 17/12/2015 | 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 | PHARNEXT SA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Belgium;Spain;Germany;Netherlands;United Kingdom | ||
| 14 | EUCTR2015-002378-19-DE (EUCTR) | 11/02/2016 | 28/09/2015 | 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 | PHARNEXT | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 15 | EUCTR2015-002378-19-BE (EUCTR) | 18/01/2016 | 19/11/2015 | 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 | PHARNEXT SA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 16 | EUCTR2015-002378-19-ES (EUCTR) | 28/12/2015 | 30/10/2015 | 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: 18.1;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 | PHARNEXT | NULL | Not 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): no | France;United States;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 17 | EUCTR2015-002378-19-FR (EUCTR) | 27/08/2015 | 27/07/2015 | 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 | PHARNEXT | NULL | Not 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): no | United States;France;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 18 | EUCTR2015-002378-19-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 | PHARNEXT | NULL | Not 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): no | France;United States;Belgium;Netherlands;Germany;United Kingdom | |||
| 19 | 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 | 350 | Phase 3 | France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy | |||
| 20 | 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 | 350 | Phase 3 | France;United States;Canada;Spain;Belgium;Denmark;Israel;Netherlands;Germany;Italy |
40. Takayasu arteritis
Clinical trials : 25 / Drugs : 50 - (DrugBank : 21) / Drug target genes : 25 - Drug target pathways : 114
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
41. Giant cell arteritis
Clinical trials : 128 / Drugs : 139 - (DrugBank : 36) / Drug target genes : 33 - Drug target pathways : 124
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
42. Polyarteritis nodosa
Clinical trials : 14 / Drugs : 27 - (DrugBank : 16) / Drug target genes : 26 - Drug target pathways : 104
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
43. Microscopic polyangiitis
Clinical trials : 87 / Drugs : 84 - (DrugBank : 20) / Drug target genes : 15 - Drug target pathways : 88
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
44. Wegener granulomatosis
Clinical trials : 92 / Drugs : 106 - (DrugBank : 27) / Drug target genes : 22 - Drug target pathways : 78
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
45. Eosinophilic granulomatosis with Polyangiitis
Clinical trials : 28 / Drugs : 42 - (DrugBank : 18) / Drug target genes : 18 - Drug target pathways : 100
| 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 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
96. Crohn disease
Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
| 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 | EUCTR2019-000852-32-NL (EUCTR) | 30/01/2020 | 08/10/2019 | 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. | 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 hydrochloride | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 122 | Phase 2 | Netherlands |