EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

PHASE3TerminatedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Partial Epilepsy
Interventions
DRUG

modified release formulation of oxcarbazepine (OXC MR)

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

DRUG

immediate release formulation of oxcarbazepine (OXC IR)

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Trial Locations (6)

Unknown

Bergisch Gladbach

Bonn

Erlangen

Freiburg im Breisgau

Göttingen

Kehl-Kork

Sponsors
All Listed Sponsors
collaborator

FGK Clinical Research GmbH

INDUSTRY

lead

Desitin Arzneimittel GmbH

INDUSTRY