9 completed. 9 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 9 |
| Phase 1 | 3 | Completed 3 |
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 |
|---|---|---|---|---|---|---|
| Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC Basimglurant with crossover to Placebo, Placebo with crossover to Basimglurant - Tuberous Sclerosis Complex | Phase 2 | Completed | Noema Pharma AG | 61 | 2022-03-03 | 2025-06-04 |
| Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants TAVT-18 (sirolimus) - Tuberous Sclerosis Complex, Epilepsy | Phase 1 / Phase 2 | Completed | Children's Hospital Medical Center, Cincinnati | 5 | 2020-09-08 | 2024-05-16 |
| Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex Early Vigabatrin, Delayed Vigabatrin (Placebo) - Tuberous Sclerosis Complex | Phase 2 | Completed | Martina Bebin | 84 | 2016-12-01 | 2024-08-19 |
| Everolimus for Cancer With TSC1 or TSC2 Mutation Everolimus - TSC1, TSC2 | Phase 2 | Completed | Dana-Farber Cancer Institute | 30 | 2014-09-01 | 2020-09-16 |
| Safety of Simvastatin in LAM and TSC Simvastatin, Sirolimus Oral Product, Everolimus Oral Product - Lymphangioleiomyomatosis, Tuberous Sclerosis Complex | Phase 1 / Phase 2 | Completed | University of Pennsylvania | 10 | 2014-03-01 | 2020-08-25 |
| A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD Everolimus - Epilepsy, Tuberous Sclerosis Complex | Phase 2 | Completed | NYU Langone Health | 15 | 2014-01-01 | 2021-09-01 |
| Rapalogues for Autism Phenotype in TSC: A Feasibility Study Sirolimus, Everolimus - Tuberous Sclerosis Complex, Self-injury | Phase 2 | Completed | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | 3 | 2013-07-01 | 2021-03-29 |
| Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) RAD001, Placebo - Tuberous Sclerosis Complex | Phase 2 | Completed | Mustafa Sahin | 52 | 2011-01-01 | 2018-01-25 |
| Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) Everolimus - Epilepsy, Tuberous Sclerosis Complex | Phase 1 / Phase 2 | Completed | Children's Hospital Medical Center, Cincinnati | 20 | 2010-01-01 | 2017-03-13 |
Tuberous Sclerosis (9) · Epilepsy (3) · Autistic Disorder (2) · Focal Cortical Dysplasia (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Lymphangioleiomyomatosis (1) · Seizures (1) · Self-Injurious Behavior (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 (9) · Neoplasms, Multiple Primary (9) · Neoplastic Syndromes, Hereditary (9) · Nervous System Diseases (9) · Nervous System Malformations (9) · Neurocutaneous Syndromes (9) · Neurodegenerative Diseases (9) · Brain Diseases (3)
Everolimus (6) · Sirolimus (3) · 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine (1) · Simvastatin (1) · Vigabatrin (1)
Children's Hospital Medical Center, Cincinnati (2) · Dana-Farber Cancer Institute (1) · Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (1) · Martina Bebin (1) · Mustafa Sahin (1) · NYU Langone Health (1) · Noema Pharma AG (1) · University of Pennsylvania (1)
United States (9) · India (1) · Israel (1) · Italy (1) · Poland (1) · Spain (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Darcy Krueger, M.D. Ph.D (1) · Darcy Krueger, MD, PhD (1) · David Kwiatkowski, MD, PhD (1) · Frank McCormack, MD (1) · Martina Bebin, MD, MPA (1) · Maryl Kreider, MD, MSCE (1) · Mustafa Sahin, MD, PhD (1) · Orrin Devinsky, MD (1) · Tanjala Gipson, MD (1) · Vera P Krymskaya, PhD, MBA (1)
PMID 21482669, PMID 23798472, PMID 31912454, PMID 35587487, PMID 37638552, PMID 39331837
U01NS092595 (1)