Multicenter Trial for Adults With Partial Seizures

Epilepsy Clinical Trial

Official title:

Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034814
• Other study ID #: IXL-201-14-189
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: March 15, 2011
• Start date: January 2002
• Est. completion date: January 2006

Study information

• Verified date: March 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Talampanel
Non-enzyme-inducing TLP 35mg TID
• Placebo
Enzyme-inducing placebo TID
• Talampanel
Enzyme-inducing Talampanel 35 mg TID
• Talampanel
Enzyme-inducing TLP 50mg TID
• Placebo
Non-enzyme-inducing placebo TID
• Talampanel
Non-enzyme-inducing TLP 25mg TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in frequency of partial seizures	Change in frequency of recognizable seizures as measured by entries in a seizure diary	12 weeks	Yes
Secondary	The number of seizure-free days and percent responders	A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline	12 weeks	No