NCT00034814

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

4 years

First QC Date

May 2, 2002

Last Update Submit

March 15, 2011

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Reduction in frequency of partial seizures

    Change in frequency of recognizable seizures as measured by entries in a seizure diary

    12 weeks

Secondary Outcomes (1)

  • The number of seizure-free days and percent responders

    12 weeks

Study Arms (6)

1

PLACEBO COMPARATOR

Enzyme-inducing placebo TID

Drug: Placebo

2

EXPERIMENTAL

Enzyme-inducing Talampanel 35 mg TID

Drug: Talampanel

3

EXPERIMENTAL

Enzyme-inducing TLP 50mg TID

Drug: Talampanel

4

PLACEBO COMPARATOR

Non-enzyme-inducing placebo TID

Drug: Placebo

5

EXPERIMENTAL

Non-enzyme-inducing TLP 25mg TID

Drug: Talampanel

6

EXPERIMENTAL

Non-enzyme-inducing TLP 35mg TID

Drug: Talampanel

Interventions

TalampanelDRUG

Non-enzyme-inducing TLP 35mg TID

6
PlaceboDRUG

Enzyme-inducing placebo TID

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients on Valproic acid, and Felbamate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

talampanel

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

January 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

March 17, 2011

Record last verified: 2011-03