NCT00351611|CompletedPhase 4ResultsFDA Drug

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

PROSPECTIVE RANDOMIZED 12-WEEK CONTROLLED STUDY OF VISUAL FIELD CHANGE IN SUBJECTS WITH PARTIAL SEIZURES RECEIVING PREGABALIN OR PLACEBO

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

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2 other identifiers

A00810962009-014269-25

Study Type

interventional

Target

187

Locations

9 countries

Sites

150

Timeline

RegisteredJul 2006

StartedJul 2006

CompletionFeb 2020

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

187

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach

9 countries

150 active sites

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

13.5 years study duration

First Submitted

Initial submission to the registry

July 11, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed

13 days until next milestone

Study Start

First participant enrolled

July 26, 2006

Completed

13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed

1 year until next milestone

Results Posted

Study results publicly available

February 21, 2021

Completed

Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

13.5 years

First QC Date

July 11, 2006

Results QC Date

February 1, 2021

Last Update Submit

April 12, 2021

Conditions

Epilepsies, Partial

Keywords

epilepsy partial seizure treatment with pregabalin or placebovision testing

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination
In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p\<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p\<0.05, p\<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants.
Baseline, Week 12 or Early Termination (any time up to Week 12)

Secondary Outcomes (2)

Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination
Baseline, Week 12 or Early Termination (any time up to Week 12)
Change From Baseline in Visual Acuity at Week 12 or Early Termination
Baseline, Week 12 or Early Termination (any time up to Week 12)

Study Arms (2)

Active

EXPERIMENTAL

Active drug

Drug: Lyrica (pregabalin)

Placebo

PLACEBO COMPARATOR

placebo comparator

Drug: placebo

Interventions

Lyrica (pregabalin)DRUG

150 mg twice a day, oral administration

Active

placeboDRUG

Twice a day, oral administration

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Sites (150)

Neurology Center, P.C.

Mobile, Alabama, 36607, United States

Location

Premier Medical Group

Mobile, Alabama, 36608, United States

Location

Neurology Clinic, PC

Northport, Alabama, 35476, United States

Location

North River Ophthalmology

Tuscaloosa, Alabama, 35406, United States

Location

Western Neurosurgery

Tucson, Arizona, 85710, United States

Location

Office of Robert Snyder, MD

Tucson, Arizona, 85712, United States

Location

REM Medical Clinical Research

Tucson, Arizona, 85712, United States

Location

NEA Baptist Clinic - Clinical Research Center

Jonesboro, Arkansas, 72401, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

NEA Baptst Clinic

Jonesboro, Arkansas, 72401, United States

Location

Chenal MRI