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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
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 2, 2002
    Last Updated
    March 15, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    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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