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Clinical Trial Summary

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01413711
Study type Interventional
Source Lundbeck LLC
Contact
Status Withdrawn
Phase Phase 4
Start date June 2012

See also
  Status Clinical Trial Phase
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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
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Completed NCT02220114 - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy N/A
Completed NCT02954887 - Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) Phase 3
Completed NCT02092883 - Evaluation of Neuroinflammation in Children With Infantile Spasms Phase 4
Completed NCT01723787 - Genetic Studies in Patients and Families With Infantile Spasms
Completed NCT00441896 - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Phase 2
Terminated NCT00442104 - Open-label Extension to Protocol 1042-0500 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Withdrawn NCT01549288 - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy Phase 2/Phase 3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