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Vision Testing in Patients Wi...

Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

Last Updated: 2021-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-26

Study Completion Date

2020-02-04

Brief Summary

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Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.

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Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

Active drug

Group Type EXPERIMENTAL

Lyrica (pregabalin)

Intervention Type DRUG

150 mg twice a day, oral administration

Placebo

placebo comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Twice a day, oral administration

Interventions

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Lyrica (pregabalin)

150 mg twice a day, oral administration

Intervention Type DRUG

placebo

Twice a day, oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Epilepsy partial seizure subjects.
* Currently taking 1 to 3 antiepileptic drugs.

Exclusion Criteria

* Pre-existing eye diseases (glaucoma).
* Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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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Neurology Center, P.C.

Mobile, Alabama, United States

Site Status

Premier Medical Group

Mobile, Alabama, United States

Site Status

Neurology Clinic, PC

Northport, Alabama, United States

Site Status

North River Ophthalmology

Tuscaloosa, Alabama, United States

Site Status

Western Neurosurgery

Tucson, Arizona, United States

Site Status

Office of Robert Snyder, MD

Tucson, Arizona, United States

Site Status

REM Medical Clinical Research

Tucson, Arizona, United States

Site Status

NEA Baptist Clinic - Clinical Research Center

Jonesboro, Arkansas, United States

Site Status

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Site Status