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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Drug: Lyrica (pregabalin); Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • DKC 2
  • Sofia, Bulgaria, 1113
    • Chetvarta nevrologichna klinika
  • Sofia, Bulgaria, 1202
    • Otdelenie po Nevrologia, Vtora MBAL
  • Sofia, Bulgaria, 1407
    • Otdelenie po nevrologia, MBAL "Tokuda Bolnitsa"
  • Sofia, Bulgaria, 1431
    • Universitetska mnogoprofilna bolnitsa za aktivno lechenieAleksandrovska, Klinika po Nevrologia
  • Sofia, Bulgaria, 1632
    • Otdelenie po nervni bolesti, MBAL Doverie
• Czechia
  • Praha 4, Czechia, 140 59
    • Fakultni Thomayerova nemocnice
  • Rychnov nad Kneznou, Czechia, 516 01
    • NEUROPS s.r.o.
  • Rychnov nad Kneznou, Czechia, 516 01
    • Ocni ambulance
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates Kft.
  • Budapest, Hungary, 1145
    • Országos Idegtudományi Intézet
  • Budapest, Hungary, 1036
    • Synexus Kft.
  • Budapest, Hungary, 1145
    • Orszagos Idegtudomanyi Intezet, Stroke es Epilepszia Osztaly
  • Hodmezovasarhely, Hungary, 6800
    • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako,
• India
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences (AIIMS)
  • New Delhi, India, 110 001
    • Dr. Ram Manohar Lohia Hospital
  • Andhra Pradesh
    • Abids, Hyderabad, Andhra Pradesh, India, 500 001
      • Netra Diagnostics (P) Ltd
    • Secunderabad, Andhra Pradesh, India, 500 003
      • Krishna Institute of Medical Sciences Ltd.
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St. John's Medical College Hospital
    • Bangalore,, Karnataka, India, 560054
      • M.S. Ramaiah Medical College and Hospitals,
    • Mangalore, Karnataka, India, 575002
      • Mallikatta Neuro Center
    • Manipal, Karnataka, India, 576 104
      • Kasturba Medical College and Hospital,
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452 001
      • Eye Site,
    • Indore, Madhya Pradesh, India, 452 001
      • M.G.M. Medical College & M. Y. Hospitals,
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 008
      • T.N.M.C and B.Y.L Nair Charitable Hospital,
    • Pune, Maharashtra, India, 411004
      • Sahyadri Speciality Hospital
    • Pune, Maharashtra, India, 411004
      • Kelkar Nursing Home
    • Pune, Maharashtra, India, 411004
      • Sahyadri Clinical Research Development Centre, A unit of Sahyadri Hospitals Ltd,
  • Tamil NADU
    • Chennai, Tamil NADU, India, 600 026
      • Vijaya Health Centre
  • Telangana
    • Hyderabad, Telangana, India, 500 082
      • Yashoda Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41931
    • Keimyung University Dongsan Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health System Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Mexico
  • Aquascalientes, Mexico, 20000
    • Dr. Ruben Munoz Flores de la Torre Ophthalmic Office
  • San Luis Potosi, Mexico, 78240
    • Hospital Central Dr. Ignacio Morones Prieto
  • Aquascalientes
    • Aguascalientes, Aquascalientes, Mexico, 20127
      • Instituto Biomedico de Investigacion AC
• Poland
  • Goczalkowice Zdroj, Poland, 43-230
    • Niepubliczny Zaklad Opieki Zdrowotnej "OKOmed" s.c.
  • Katowice, Poland, 40-662
    • NZOZ Tommed
  • Katowice, Poland, 40-683
    • Centrum Medyczne Dendryt
  • Krakow, Poland, 30-040
    • Prywatny Gabinet Psychiatryczny dr Ewa Dereszak-Kozanecka
  • Krakow, Poland, 30-319
    • Prywatny Gabinet Okulistyczny dr. n.med. Teresa Gedliczka
  • Krakow, Poland, 31-209
    • NZOZ Centrum Leczenia Padaczki i Migreny
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao hospital,
  • Khon Kaen
    • Muang, Khon Kaen, Thailand, 40002
      • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Neurology Center, P.C.
    • Mobile, Alabama, United States, 36608
      • Premier Medical Group
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, PC
    • Tuscaloosa, Alabama, United States, 35406
      • North River Ophthalmology
  • Arizona
    • Tucson, Arizona, United States, 85712
      • REM Medical Clinical Research
    • Tucson, Arizona, United States, 85710
      • Western Neurosurgery
    • Tucson, Arizona, United States, 85712
      • Office of Robert Snyder, MD
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic - Clinical Research Center
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptst Clinic
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc.
    • Little Rock, Arkansas, United States, 72205
      • Eye Care Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Chenal MRI
    • Little Rock, Arkansas, United States, 72205
      • Radiology Consultants
  • California
    • Costa Mesa, California, United States, 92627
      • Barbara Swartz, MD, Inc
    • Glendale, California, United States, 91206
      • Mireille P. Hamparian
    • Irvine, California, United States, 92604
      • Lakeside Vision Center
    • Long Beach, California, United States, 90813
      • Eye Treatment Center, Inc.
    • Newport Beach, California, United States, 92658
      • Hoag Memorial Hospital Presbyterian
    • Paramount, California, United States, 90723
      • Clinical Innovations, Inc.
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8018
      • Yale University School Of Medicine
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc
    • Bradenton, Florida, United States, 34209
      • The Eye Associates
    • Destin, Florida, United States, 32541
      • SJS Clinical Research, Inc.
    • Fort Walton Beach, Florida, United States, 32547
      • White Wilson Medical Center
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic, Inc.
    • Miami, Florida, United States, 33134
      • Dr. Raul F. Masvidal, MD, PA
    • Port Charlotte, Florida, United States, 33952
      • Medsol Clinical Research Center, Inc
    • Port Charlotte, Florida, United States, 33948
      • David M Klein, MD, PA
    • Sarasota, Florida, United States, 34239
      • Sarasota Retinal Institute
    • Sarasota, Florida, United States, 34232
      • Intercoastal Medical Research Center
    • Sarasota, Florida, United States, 34239
      • Dr. Nicholas Monsul
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Coastal Research Associates, LLC
    • Suwanee, Georgia, United States, 30024
      • Comprehensive Neurology Specialists, PC
  • Kansas
    • Wichita, Kansas, United States, 67203
      • Professional Research Network of Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo-Retinal Consultants and Surgeons
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • NeuroMedical Clinic of Central Louisiana
    • Alexandria, Louisiana, United States, 71303
      • Louisiana Eye and Laser Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Eye Associates, P.A.
    • Columbia, Maryland, United States, 21044
      • Glaucoma Plus Eye Care, LLC
    • Fulton, Maryland, United States, 20759
      • Center for Brain and Neuro Care, LLC
    • Hagerstown, Maryland, United States, 21740
      • The Center for Clinical Research
    • Hagerstown, Maryland, United States, 21740
      • Bergman Eye Associates
    • Hagerstown, Maryland, United States, 21740
      • Neurology Consultant, P.A.
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
    • Detroit, Michigan, United States, 48201
      • Harper Hospital
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Care Center
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology, Ltd
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
    • Columbia, Missouri, United States, 65401
      • CCN-MS & Neurology Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Neurology Center of Las Vegas
    • Las Vegas, Nevada, United States, 89119
      • Nevada Eye Care
  • New Jersey
    • Englewood Cliffs, New Jersey, United States, 07632
      • Institute of Neurological Care
    • Paramus, New Jersey, United States, 07652
      • Office of Patricia Burke, MD
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Amherst, New York, United States, 14226
      • Western New York Ophthalmology Group
    • Buffalo, New York, United States, 14203
      • Buffalo General Hospital
    • Buffalo, New York, United States, 14209
      • The Jacobs Neurological Institute Comprehensive Epilepsy Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Guilford Neurologic Associates, Inc
    • Greensboro, North Carolina, United States, 27408
      • Digby Eye Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Clinical Research of Winston-Salem
    • Winston-Salem, North Carolina, United States, 27103
      • Salem Neurological Center, PA
    • Winston-Salem, North Carolina, United States, 27107
      • Office of Dr. James D. Branch, MD
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Jeffrey Shaver, MD
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Clinical Trials of America, Inc.
    • Eugene, Oregon, United States, 97401
      • Pacific Women's Center, LLC
    • Eugene, Oregon, United States, 97401
      • Oregon Eye Consultants, LLC
    • Springfield, Oregon, United States, 97477
      • Oregon Neurology Associates
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Health System
    • Beaver, Pennsylvania, United States, 15009
      • Daniel J. Nadler, MD, PC
    • Monaca, Pennsylvania, United States, 15061
      • Valley Neurological Associates
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Center For Advanced Eye Care
    • Greer, South Carolina, United States, 29650
      • Premier Neurology, PC
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
    • Mount Pleasant, South Carolina, United States, 29464
      • Glaucoma Consultants and Center for Eye Research, PA
    • Mount Pleasant, South Carolina, United States, 29464
      • Tidewater Neurology
    • Spartanburg, South Carolina, United States, 29302
      • Neurology Centers of the Carolinas
    • Spartanburg, South Carolina, United States, 29303
      • Piedmont Eye Associates
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Envision Eye Care
    • Johnson City, Tennessee, United States, 37604
      • Tri-state Mountain Neurology Associates, PC
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center
    • Memphis, Tennessee, United States, 38104
      • Semmes Murphey Clinic
    • Memphis, Tennessee, United States, 38120
      • Semmes Murphey Clinic
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Austin, Texas, United States, 78731
      • Texan Eye
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of Texas
    • Houston, Texas, United States, 77058
      • Egret Bay Neurology, PA
    • Longview, Texas, United States, 75601
      • DeHaven Eye Clinic
    • Longview, Texas, United States, 75605
      • Diagnostic Clinic of Longview Center for Clinical Research
    • Longview, Texas, United States, 75605
      • Diagnostic Clinic of Longview, PA
    • Webster, Texas, United States, 77598
      • Coastal Eye Associates
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Neurological Associates Sarah Cannon Cancer Institute;
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Eye Institute
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin Department of Neurology Froedtert Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo comparator	Drug: placebo; Twice a day, oral administration
Experimental: Active; Active drug	Drug: Lyrica (pregabalin); 150 mg twice a day, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination	Mean deviation (MD) is a global index of visual field depression. The MD ranges from 0 decibels (no defect) to about -32 decibels (end-stage damage), higher scores indicate worse condition. It is derived from the Humphrey 24-2 SITA standard visual field analyzer. Change in mean deviation score from baseline to Week 12 or termination was computed for each participant. As planned, for each participant, the worst eye (eye with the greatest decrease in mean deviation) was used in the analysis and data is reported for same.	Baseline, Week 12 or Early Termination (any time up to Week 12)
Change From Baseline in Visual Acuity at Week 12 or Early Termination	Visual acuity best-corrected (with glasses or best possible glasses prescription) was measured using early treatment diabetic retinopathy study (ETDRS) charts. There were 2 ETDRS charts. The letters on chart A were read using the right eye and on chart B using the left eye. The participants started from the top of the chart to down. The participants read down the chart until they reached a row where a minimum of 3 letters on a line could not be read. The participants were scored by number of letters identified correctly. Range was from 0 to 70, with higher scores indicate better visual acuity. As planned, for each participant, the worst eye (eye with the greatest decrease in visual acuity) was used in the analysis and data is reported for same.	Baseline, Week 12 or Early Termination (any time up to Week 12)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2006
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 4, 2020

Study Registration Dates

• First Submitted: July 11, 2006
• First Submitted That Met QC Criteria: July 11, 2006
• First Posted (Estimate): July 13, 2006

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: vision testing; epilepsy partial seizure treatment with pregabalin or placebo
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081096; 2009-014269-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No