Baclofen (DrugBank: Baclofen)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 1 |
| 10 | シャルコー・マリー・トゥース病 | 10 |
| 13 | 多発性硬化症／視神経脊髄炎 | 14 |
| 18 | 脊髄小脳変性症（多系統萎縮症を除く。） | 1 |
| 149 | 片側痙攣・片麻痺・てんかん症候群 | 1 |
| 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 | EUCTR2010-020257-13-IT (EUCTR) | 30/07/2010 | 05/07/2010 | A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS | A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS | PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS MedDRA version: 9.1;Level: SOC;Classification code 10029205 | Trade Name: MYONAL*30CPR RIV 100MG INN or Proposed INN: EPERISONE Trade Name: LIORESAL*50CPR 10MG INN or Proposed INN: Baclofen | AZIENDA OSPEDALIERO-UNIVERSITARIA | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy |
| 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 | EUCTR2015-002379-81-NL (EUCTR) | 08/01/2018 | 28/03/2017 | 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 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 | 290 | Phase 3 | France;United States;Canada;Belgium;Spain;Germany;Netherlands;United Kingdom | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2010-023097-40-FR (EUCTR) | 29/11/2010 | 04/10/2010 | A Phase II, Randomised, Placebo-Controlled Trial of the Safety, Efficacy, Pharmacodynamics of PTX3003 in Patients with Charcot-Marie-Tooth Disease Type 1A - non applicable | A Phase II, Randomised, Placebo-Controlled Trial of the Safety, Efficacy, Pharmacodynamics of PTX3003 in Patients with Charcot-Marie-Tooth Disease Type 1A - non applicable | Charcot-Marie-Tooth disease (type 1A). MedDRA version: 12.1;Level: LLT;Classification code 10008414;Term: Charcot-Marie-Tooth disease | Product Name: non applicable Product Code: PXT3003 INN or Proposed INN: Baclofen INN or Proposed INN: Naltrexone INN or Proposed INN: Sorbitol Product Name: non applicable Product Code: PXT3003 INN or Proposed INN: Baclofen INN or Proposed INN: Naltrexone INN or Proposed INN: Sorbitol Product Name: non applicable Product Code: PXT3003 INN or Proposed INN: Baclofen INN or Proposed INN: Naltrexone INN or Proposed INN: Sorbitol | Pharnext | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France |
| 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 | EUCTR2017-004100-22-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 2 | EUCTR2017-004101-40-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 3 | EUCTR2017-004101-40-BG (EUCTR) | 23/03/2018 | 09/01/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 4 | EUCTR2017-004101-40-PL (EUCTR) | 21/03/2018 | 12/02/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 5 | EUCTR2017-004100-22-PL (EUCTR) | 21/03/2018 | 09/02/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 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 |
| 6 | EUCTR2017-004100-22-BG (EUCTR) | 16/03/2018 | 08/01/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 7 | EUCTR2016-001356-22-HU (EUCTR) | 13/07/2016 | 26/04/2016 | A STUDY OF THE SAFETY AND EFFECTS OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH TIGHTNESS, STIFFNESS AND PULL OF MUSCLES DUE TO MULTIPLE SCLEROSIS | A PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS | Spasticity due to multiple sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 10 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Baclofen Tablets USP Product Name: Baclofen Tablets USP 10 mg INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 20 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 30mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 40mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 50 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN | Sun Pharma Advanced Research Company Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Hungary;Ukraine;Russian Federation;Germany | ||
| 8 | NCT01743651 (ClinicalTrials.gov) | November 2012 | 28/11/2012 | Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis | A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: arbaclofen;Drug: baclofen;Drug: Placebo | Osmotica Pharmaceutical Corp. | NULL | Completed | 18 Years | 65 Years | Both | 353 | Phase 3 | United States;Russian Federation;Ukraine |
| 9 | NCT00914290 (ClinicalTrials.gov) | April 2009 | 2/6/2009 | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IR | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States |
| 10 | EUCTR2007-000236-16-LV (EUCTR) | 04/07/2007 | 02/04/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-25 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 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 |
| 11 | NCT00488839 (ClinicalTrials.gov) | June 2007 | 18/6/2007 | IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | Multiple Sclerosis | Drug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mg | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 173 | Phase 3 | United States;Canada;Estonia;Latvia;Ukraine |
| 12 | EUCTR2007-000236-16-EE (EUCTR) | 28/05/2007 | 16/03/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 13 | NCT00139789 (ClinicalTrials.gov) | January 2005 | 29/8/2005 | A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis | A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis | Multiple Sclerosis | Drug: Kemstro | UCB Pharma | NULL | Completed | 18 Years | 65 Years | Both | 60 | Phase 3 | United States |
| 14 | JPRN-JapicCTI-050031 | 06/09/2005 | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injury | Intervention name : Baclofen Dosage And administration of the intervention : Intertheacal injection | DAIICHI SANKYO COMPANY, LIMITED | NULL | BOTH | Phase 4 | NULL |
| 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 | JPRN-JapicCTI-050031 | 06/09/2005 | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injury | Intervention name : Baclofen Dosage And administration of the intervention : Intertheacal injection | DAIICHI SANKYO COMPANY, LIMITED | NULL | BOTH | Phase 4 | NULL |
| 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 | NCT03860662 (ClinicalTrials.gov) | February 26, 2019 | 8/2/2019 | Nociceptive Flexor Reflex and Antispastic Treatmens | Research Assistant Doctor | Stroke Sequelae;Spastic Hemiplegia | Diagnostic Test: Nociceptor flexor reflex;Drug: Botox;Drug: Baclofen | Mustafa Kemal University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 30 | Phase 4 | Turkey |