Rs-baclofen (DrugBank: Baclofen)
1 disease| 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 | 3 |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 |