Pregabalin Epilepsy Add-On Trial

NCT ID: NCT00141258

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-08-31

Brief Summary

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To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Detailed Description

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Conditions

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Partial Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
* Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion Criteria

* Have a treatable cause of seizures
* Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Daegu, , South Korea

Site Status

Pfizer Investigational Site

Daejeon, , South Korea

Site Status

Pfizer Investigational Site

Gwangju, , South Korea

Site Status

Pfizer Investigational Site

Incheon, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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A0081079

Identifier Type: -

Identifier Source: org_study_id

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