Arbaclofen Extended Release Tablets
( DrugBank: Arbaclofen / KEGG DRUG: Arbaclofen )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 7 |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,340 / Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
Showing 1 to 7 of 7 trials
| 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) | 27/04/201820180427 | 16/05/201920190516 | 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) A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Ef ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 2 | EUCTR2017-004101-40-HR (EUCTR) | 27/04/201820180427 | 16/05/201920190516 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticit ... | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multi ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 3 | EUCTR2017-004101-40-BG (EUCTR) | 23/03/201820180323 | 09/01/201820180109 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticit ... | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multi ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 4 | EUCTR2017-004100-22-PL (EUCTR) | 21/03/201820180321 | 09/02/201820180209 | 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) A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Ef ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 5 | EUCTR2017-004101-40-PL (EUCTR) | 21/03/201820180321 | 12/02/201820180212 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticit ... | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multi ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 6 | EUCTR2017-004100-22-BG (EUCTR) | 16/03/201820180316 | 08/01/201820180108 | 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) A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Ef ... | 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] Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 1 ... | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen O ... | 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 United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of ... | ||
| 7 | NCT01844232 (ClinicalTrials.gov) | April 201320130400 | 24/4/201320130424 | One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects Wit ... | A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extende ... | Multiple Sclerosis;Spasticity | Drug: arbaclofen | RVL Pharmaceuticals, Inc. | Osmotica Pharmaceutical US LLC | Completed | 18 Years | 70 Years | All | 150 | Phase 3 | United States;Russian Federation;Ukraine |