Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

Phase 2

Terminated

• Conditions: Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Mixed Oligoastrocytoma
• Interventions: Drug: Talampanel

• Registration Number: NCT00062504
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.

Detailed Description

To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.

Study Timeline

• Study First Submitted: 2003-06-06
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Study Start: 2003-07
• Primary Completion: 2006-01
• Study Completion: 2006-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Talampanel	Valproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3
3	Talampanel	Enzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3
2	Talampanel	Non-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3