drugset / Trial / NCT02849457
Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Phase 2
Completed
84 enrolled
Martina Bebin
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure
Timeline
- Start
- 2016-12
- Primary completion
- 2023-04-26
- Completion
- 2023-05-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Delayed Vigabatrin (Placebo) vs Early Vigabatrin; p = 0.8681; Mean Difference (Final Values) -0.6565 (95% CI -8.5567 to 7.2436); Mixed Models Analysis NCT02849457 ↗
paper Bayley-III cognitive composite scores at 24 months were similar for participants randomized to vigabatrin or placebo. PMID 37638552 ↗
Publications
- Results Bebin EM, Peters JM, Porter BE, McPherson TO, O'Kelley S, Sahin M, Taub KS, Rajaraman R, Randle SC, McClintock WM, Koenig MK, Frost MD, Northrup HA, Werner K, Nolan DA, Wong M, Krefting JL, Biasini F, Peri K, Cutter G, Krueger DA; PREVeNT Study Group. Early Treatment with Vigabatrin Does Not Decrease Focal Seizures or Improve Cognition in Tuberous Sclerosis Complex: The PREVeNT Trial. Ann Neurol. 2023 Aug 28:10.1002/ana.26778. doi: 10.1002/ana.26778. Online ahead of print.
- van der Poest Clement E, Jansen FE, Braun KPJ, Peters JM. Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex. Paediatr Drugs. 2020 Feb;22(1):73-84. doi: 10.1007/s40272-019-00376-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vigabatrin | Small molecule | 100 mg/kg | — |