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

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lyrica (pregabalin)
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial focused on measuring epilepsy partial seizure treatment with pregabalin or placebo, vision testing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurology Center, P.C.
  • Premier Medical Group
  • Neurology Clinic, PC
  • North River Ophthalmology
  • Western Neurosurgery
  • Office of Robert Snyder, MD
  • REM Medical Clinical Research
  • NEA Baptist Clinic - Clinical Research Center
  • NEA Baptist Clinic
  • NEA Baptst Clinic
  • Chenal MRI
  • Clinical Trials, Inc.
  • Eye Care Arkansas
  • Radiology Consultants
  • University of Arkansas for Medical Sciences
  • Barbara Swartz, MD, Inc
  • Mireille P. Hamparian
  • Lakeside Vision Center
  • Eye Treatment Center, Inc.
  • Hoag Memorial Hospital Presbyterian
  • Clinical Innovations, Inc.
  • Yale University School of Medicine
  • Bradenton Research Center, Inc
  • The Eye Associates
  • SJS Clinical Research, Inc.
  • White Wilson Medical Center
  • Pharmax Research Clinic, Inc.
  • Dr. Raul F. Masvidal, MD, PA
  • David M Klein, MD, PA
  • Medsol Clinical Research Center, Inc
  • Intercoastal Medical Research Center
  • Dr. Nicholas Monsul
  • Sarasota Retinal Institute
  • Coastal Research Associates, LLC
  • Comprehensive Neurology Specialists, PC
  • Professional Research Network of Kansas
  • Vitreo-Retinal Consultants and Surgeons
  • Neuromedical Clinic of Central Louisiana
  • Louisiana Eye and Laser Center
  • University of Maryland Eye Associates, P.A.
  • University of Maryland School of Medicine
  • University of Maryland
  • Glaucoma Plus Eye Care, LLC
  • Center for Brain and Neuro Care, LLC
  • Bergman Eye Associates
  • Neurology Consultant, P.A.
  • The Center for Clinical Research
  • Harper Hospital
  • Wayne State University
  • Fraser Eye Care Center
  • Minneapolis Clinic of Neurology, Ltd
  • University of Missouri
  • CCN-MS & Neurology Associates
  • Nevada Eye Care
  • Neurology Center of Las Vegas
  • Institute of Neurological Care
  • Office of Patricia Burke, MD
  • Dent Neurologic Institute
  • Dent Neurosciences Research Center
  • Western New York Ophthalmology Group
  • Buffalo General Hospital
  • The Jacobs Neurological Institute Comprehensive Epilepsy Center
  • Guilford Neurologic Associates, Inc
  • Digby Eye Associates
  • Clinical Research of Winston-Salem
  • Salem Neurological Center, PA
  • Office of Dr. James D. Branch, MD
  • MetroHealth Medical Center
  • The Cleveland Clinic
  • The Ohio State University Medical Center
  • Jeffrey Shaver, MD
  • Sooner Clinical Research
  • Clinical Trials of America, Inc.
  • Oregon Eye Consultants, LLC
  • Pacific Women's Center, LLC
  • Oregon Neurology Associates
  • Daniel J. Nadler, MD, PC
  • Heritage Valley Health System
  • Valley Neurological Associates
  • Center For Advanced Eye Care
  • Premier Neurology, PC
  • Coastal Carolina Research Center
  • Glaucoma Consultants and Center for Eye Research, PA
  • Tidewater Neurology
  • Neurology Centers of the Carolinas
  • Piedmont Eye Associates
  • Envision Eye Care
  • Tri-state Mountain Neurology Associates, PC
  • Semmes Murphey Clinic
  • Semmes Murphey Clinic
  • University of Tennessee Health Science Center
  • FutureSearch Trials of Neurology
  • Texan Eye
  • Texas Neurology, PA
  • Glaucoma Associates of Texas
  • Egret Bay Neurology, PA
  • DeHaven Eye Clinic
  • Diagnostic Clinic of Longview Center for Clinical Research
  • Diagnostic Clinic of Longview, PA
  • Coastal Eye Associates
  • Neurological Associates Sarah Cannon Cancer Institute;
  • Medical College of Wisconsin Department of Neurology Froedtert Memorial Hospital
  • Medical College of Wisconsin Eye Institute
  • DKC 2
  • Chetvarta nevrologichna klinika
  • Otdelenie po Nevrologia, Vtora MBAL
  • Otdelenie po nevrologia, MBAL "Tokuda Bolnitsa"
  • Universitetska mnogoprofilna bolnitsa za aktivno lechenieAleksandrovska, Klinika po Nevrologia
  • Otdelenie po nervni bolesti, MBAL Doverie
  • Fakultni Thomayerova nemocnice
  • NEUROPS s.r.o.
  • Ocni ambulance
  • Synexus Kft.
  • Budapest Retina Associates Kft.
  • Orszagos Idegtudomanyi Intezet, Stroke es Epilepszia Osztaly
  • Orszagos Idegtudomanyi Intezet
  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako,
  • Netra Diagnostics (P) Ltd
  • Krishna Institute of Medical Sciences Ltd.
  • King George Hospital
  • M.S. Ramaiah Medical College and Hospitals,
  • St. John's Medical College Hospital
  • Mallikatta Neuro Center
  • Kasturba Medical College and Hospital,
  • Eye Site,
  • M.G.M. Medical College & M. Y. Hospitals,
  • T.N.M.C and B.Y.L Nair Charitable Hospital,
  • Kelkar Nursing Home
  • Sahyadri Clinical Research Development Centre, A unit of Sahyadri Hospitals Ltd,
  • Sahyadri Speciality Hospital
  • Vijaya Health Centre
  • Yashoda Hospital
  • Dr. Ram Manohar Lohia Hospital
  • All India Institute of Medical Sciences (AIIMS)
  • Keimyung University Dongsan Hospital
  • Seoul National University Hospital
  • Yonsei University Health System Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Instituto Biomedico de Investigacion AC
  • Dr. Ruben Munoz Flores de la Torre Ophthalmic Office
  • Hospital Central Dr. Ignacio Morones Prieto
  • Niepubliczny Zaklad Opieki Zdrowotnej "OKOmed" s.c.
  • NZOZ Tommed
  • Centrum Medyczne Dendryt
  • Prywatny Gabinet Psychiatryczny dr Ewa Dereszak-Kozanecka
  • Prywatny Gabinet Okulistyczny dr. n.med. Teresa Gedliczka
  • NZOZ Centrum Leczenia Padaczki i Migreny
  • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
  • Phramongkutklao hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Active drug

placebo comparator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 11, 2006
Last Updated
April 12, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00351611
Brief Title
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Official Title
PROSPECTIVE RANDOMIZED 12-WEEK CONTROLLED STUDY OF VISUAL FIELD CHANGE IN SUBJECTS WITH PARTIAL SEIZURES RECEIVING PREGABALIN OR PLACEBO
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 2006 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
epilepsy partial seizure treatment with pregabalin or placebo, vision testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Active drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
Lyrica (pregabalin)
Intervention Description
150 mg twice a day, oral administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Twice a day, oral administration
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Week 12 or Early Termination (any time up to Week 12)
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination
Description
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.
Time Frame
Baseline, Week 12 or Early Termination (any time up to Week 12)
Title
Change From Baseline in Visual Acuity at Week 12 or Early Termination
Description
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.
Time Frame
Baseline, Week 12 or Early Termination (any time up to Week 12)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081096&StudyName=Vision%20Testing%20in%20Patients%20with%20Partial%20Seizures%20Receiving%20Either%20Lyrica%20or%20%20Placebo
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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