4 completed, 2 recruiting, 1 active not recruiting, 1 terminated. 9 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 4, Recruiting 2, Active not recruiting 1, Terminated 1, Unknown 1 |
| Phase 2 | 2 | Recruiting 1, Unknown 1 |
Follow Tuberous Sclerosis Complex: new trials by email Literature Review of Tuberous Sclerosis Complex trials Research Report on Tuberous Sclerosis Complex
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex Rapamycin, Placebo - Tuberous Sclerosis Complex | Phase 3 | Recruiting | Katarzyna Kotulska | 200 | 2023-01-23 | 2026-10-22 |
| Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC NPC-12Y gel, NPC-12Y placebo gel - Tuberous Sclerosis Complex | Phase 3 | Completed | Nobelpharma | 43 | 2022-06-01 | 2024-11-22 |
| Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy Ganaxolone - Tuberous Sclerosis Complex | Phase 3 | Terminated | Marinus Pharmaceuticals | 117 | 2022-05-16 | 2025-10-01 |
| Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy Ganaxolone, Placebo - Tuberous Sclerosis Complex | Phase 3 | Completed | Marinus Pharmaceuticals | 129 | 2022-04-01 | 2025-07-11 |
| Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants Vigabatrin, Rapamycin, Placebo - Tuberous Sclerosis Complex | Phase 2 / Phase 3 | Recruiting | Katarzyna Kotulska | 60 | 2021-05-07 | 2026-10-22 |
| Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment everolimus - Tuberous Sclerosis Complex | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 206 | 2017-08-23 | 2026-08-21 |
| An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) GWP42003-P - Tuberous Sclerosis Complex, Seizures | Phase 3 | Completed | Jazz Pharmaceuticals | 199 | 2016-08-31 | 2022-07-14 |
| A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) GWP42003-P, Placebo - Tuberous Sclerosis Complex, Seizures | Phase 3 | Completed | Jazz Pharmaceuticals | 224 | 2016-04-06 | 2022-09-28 |
| Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex Everolimus, Placebo - Tuberous Sclerosis Complex, TSC Related Cognitive Disability | Phase 2 / Phase 3 | Unknown | Erasmus Medical Center | 60 | 2012-11-01 | 2015-05-05 |
Tuberous Sclerosis (9) · Seizures (3) · Epilepsy (2) · Autistic Disorder (1) · Drug Resistant Epilepsy (1) · Intellectual Disability (1) · Neoplasms (1)
Congenital Abnormalities (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Genetic Diseases, Inborn (9) · Hamartoma (9) · Heredodegenerative Disorders, Nervous System (9) · Malformations of Cortical Development (9) · Malformations of Cortical Development, Group I (9) · Neoplasms, Multiple Primary (9) · Neoplastic Syndromes, Hereditary (9) · Nervous System Diseases (9) · Nervous System Malformations (9) · Neurocutaneous Syndromes (9) · Neurodegenerative Diseases (9) · Neoplasms (8) · Neurologic Manifestations (4)
Cannabidiol (2) · Everolimus (2) · Sirolimus (2) · ganaxolone (2) · Fluid Therapy (1) · Vigabatrin (1)
Jazz Pharmaceuticals (2) · Katarzyna Kotulska (2) · Marinus Pharmaceuticals (2) · Erasmus Medical Center (1) · Nobelpharma (1) · Novartis Pharmaceuticals (1)
United States (5) · Australia (4) · Poland (4) · Spain (4) · United Kingdom (4) · Canada (3) · France (3) · Italy (3) · China (2) · Germany (2) · Israel (2) · Japan (2) · Netherlands (2) · Belgium (1) · Colombia (1)
Katarzyna Kotulska-Jozwiak (1)
PMID 34957550, PMID 31217257, PMID 33346789, PMID 35175622, PMID 38441854
2015 (2)