158. Tuberous sclerosis Clinical trials / Disease details
Clinical trials : 112 / Drugs : 71 - (DrugBank : 19) / Drug target genes : 35 - Drug target pathways : 118
| 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 | NCT04987463 (ClinicalTrials.gov) | May 7, 2021 | 28/5/2021 | Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants | Randomized, Placebo-controlled, Double-blind and Double-dummy Clinical Trial Comparing the Safety, Tolerability, and Efficacy of Vigabatrin and Rapamycin in a Preventive Treatment of Infants With Tuberous Sclerosis Complex | Tuberous Sclerosis Complex | Drug: Vigabatrin;Drug: Rapamycin;Drug: Placebo | Katarzyna Kotulska | NULL | Recruiting | 4 Weeks | 16 Weeks | All | 60 | Phase 2/Phase 3 | Poland |
| 2 | NCT02849457 (ClinicalTrials.gov) | December 2016 | 13/7/2016 | Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex | Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC | Tuberous Sclerosis Complex | Drug: Vigabatrin;Drug: Placebo | Martina Bebin | National Institute of Neurological Disorders and Stroke (NINDS) | Active, not recruiting | N/A | 6 Months | All | 84 | Phase 2 | United States |
| 3 | EUCTR2013-005528-40-BE (EUCTR) | 11/12/2014 | 17/11/2014 | Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex | Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex - EPISTOP | epilepsy in tuberous sclerosis complex (TSC);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: vigabatrin (sabril) Product Name: vigabatrin INN or Proposed INN: VIGABATRIN | Vrije Universiteit Brussel | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Belgium;Netherlands | |||
| 4 | EUCTR2013-005528-40-NL (EUCTR) | 05/12/2014 | 14/07/2014 | Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex. | Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex. - EPISTOP | Epilepsy in tuberous sclerosis complex (TSC) MedDRA version: 17.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigabatrin (Sabril) Product Name: vigabatrin | The Children's Memorial Health Institute | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Belgium;Netherlands | |||
| 5 | NCT01266291 (ClinicalTrials.gov) | August 2010 | 22/12/2010 | Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients | Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study | Complex Partial Seizures | Drug: vigabatrin | University of Pennsylvania | H. Lundbeck A/S | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United States |
| 6 | EUCTR2020-003231-19-PL (EUCTR) | 09/10/2020 | Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous Sclerosis Complex symptoms in infants in the randomized clinical trial | Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with Tuberous Sclerosis Complex (ViRap) - ViRap | Tuberous Sclerosis ComplexEpilepsyTumors associated with Tuberous Sclerosis Complex;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SABRIL 500 mg, granules for oral solution Trade Name: RAPAMUNE 1 mg/ml oral solution | The Children's Memorial Health Institute | NULL | NA | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Poland |