drugset
drugset / Trial / NCT01284530

Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

NCT01284530 ↗

Phase 1/2 Completed 30 enrolled Supernus Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.

Timeline

Start
2011-01
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TPM XR Unknown 25 mg Oral
Subject TPM XR Unknown 50 mg Oral
Subject TPM XR Unknown 100 mg Oral
Subject TPM XR Unknown 200 mg Oral

Indications

epilepsy