Multicenter Trial for Adults With Partial Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Talampanel
Placebo
Talampanel
Talampanel
Placebo
Talampanel
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
Enzyme-inducing placebo TID
Enzyme-inducing Talampanel 35 mg TID
Enzyme-inducing TLP 50mg TID
Non-enzyme-inducing placebo TID
Non-enzyme-inducing TLP 25mg TID
Non-enzyme-inducing TLP 35mg TID
Outcomes
Primary Outcome Measures
Reduction in frequency of partial seizures
Change in frequency of recognizable seizures as measured by entries in a seizure diary
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00034814
First Posted
May 2, 2002
Last Updated
March 15, 2011
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00034814
Brief Title
Multicenter Trial for Adults With Partial Seizures
Official Title
Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Enzyme-inducing placebo TID
Arm Title
2
Arm Type
Experimental
Arm Description
Enzyme-inducing Talampanel 35 mg TID
Arm Title
3
Arm Type
Experimental
Arm Description
Enzyme-inducing TLP 50mg TID
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Non-enzyme-inducing placebo TID
Arm Title
5
Arm Type
Experimental
Arm Description
Non-enzyme-inducing TLP 25mg TID
Arm Title
6
Arm Type
Experimental
Arm Description
Non-enzyme-inducing TLP 35mg TID
Intervention Type
Drug
Intervention Name(s)
Talampanel
Intervention Description
Non-enzyme-inducing TLP 35mg TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Enzyme-inducing placebo TID
Intervention Type
Drug
Intervention Name(s)
Talampanel
Intervention Description
Enzyme-inducing Talampanel 35 mg TID
Intervention Type
Drug
Intervention Name(s)
Talampanel
Intervention Description
Enzyme-inducing TLP 50mg TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Non-enzyme-inducing placebo TID
Intervention Type
Drug
Intervention Name(s)
Talampanel
Intervention Description
Non-enzyme-inducing TLP 25mg TID
Primary Outcome Measure Information:
Title
Reduction in frequency of partial seizures
Description
Change in frequency of recognizable seizures as measured by entries in a seizure diary
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The number of seizure-free days and percent responders
Description
A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Multicenter Trial for Adults With Partial Seizures
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