Infantile Spasms Clinical Trial
Official title:
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the
dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin
(Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6
years) and 500 mg granules for oral solution sachets (for infants and children below 6
years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is
needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often
required.
This study is a descriptive, non-randomized, open label multi-centric acceptability study in
infants and children affected with infantile spasms. The primary objective is to describe the
adherence to the new formulation. Secondary objectives include:
- evaluation of the palatability and user-friendliness of the new treatment,
- evaluation of the pharmacokinetic parameters of the new formulation,
- PK parameters,
- evaluation of the tolerance,
- measurement of taurine plasma levels. This study will recruit up to 40 patients with
infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23
clinical sites in France.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02299115 -
Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
|
Phase 3 | |
| Completed |
NCT02885389 -
Molecular Genetics in Infantile Spasms
|
N/A | |
| Completed |
NCT01006811 -
Use of the Modified Atkins Diet in Infantile Spasms
|
Phase 2/Phase 3 | |
| Completed |
NCT01828437 -
Addition of Pyridoxine to Prednisolone in Infantile Spasms
|
Phase 3 | |
| Recruiting |
NCT01858285 -
Genetics of Epilepsy and Related Disorders
|
||
| Completed |
NCT00552045 -
Epilepsy Phenome/Genome Project
|
||
| Completed |
NCT02954887 -
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
|
Phase 3 | |
| Completed |
NCT01723787 -
Genetic Studies in Patients and Families With Infantile Spasms
|
||
| Completed |
NCT02092883 -
Evaluation of Neuroinflammation in Children With Infantile Spasms
|
Phase 4 | |
| Withdrawn |
NCT01413711 -
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
|
Phase 4 | |
| Terminated |
NCT00442104 -
Open-label Extension to Protocol 1042-0500
|
Phase 2 | |
| Completed |
NCT00441896 -
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
|
Phase 2 | |
| Withdrawn |
NCT01549288 -
Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy
|
Phase 2/Phase 3 | |
| Completed |
NCT01575639 -
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
|
Phase 3 | |
| Not yet recruiting |
NCT06315829 -
Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
|
||
| Completed |
NCT01073579 -
Sabril Patient Registry
|
N/A | |
| Completed |
NCT02953548 -
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
|
Phase 3 | |
| Completed |
NCT00001325 -
Metabolic Abnormalities in Children With Epilepsy
|
N/A | |
| Completed |
NCT00968136 -
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
|
N/A |