Sparc0921 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 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 | 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 |