Multicenter Trial for Adults With Partial Seizures

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Talampanel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034814

IXL-201-14-189

Details and patient eligibility

About

To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.

Full description

A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.

Enrollment: 190 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• must weigh greater than or equal to 40kg
• Patients must have diagnosis of partial seizures
• At least 3 observable partial seizures a month
• Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.

Exclusion:

• Patients on Valproic acid, and Felbamate

Trial design

190 participants in 6 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Enzyme-inducing placebo TID

Treatment:

Drug: Placebo

Drug: Placebo

2

Experimental group

Description:

Enzyme-inducing Talampanel 35 mg TID

Treatment:

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

3

Experimental group

Description:

Enzyme-inducing TLP 50mg TID

Treatment:

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

4

Placebo Comparator group

Description:

Non-enzyme-inducing placebo TID

Treatment:

Drug: Placebo

Drug: Placebo

5

Experimental group

Description:

Non-enzyme-inducing TLP 25mg TID

Treatment:

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

6

Experimental group

Description:

Non-enzyme-inducing TLP 35mg TID

Treatment:

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel

Drug: Talampanel