Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
- Registration Number
- NCT00351611
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- Epilepsy partial seizure subjects.
- Currently taking 1 to 3 antiepileptic drugs.
- Pre-existing eye diseases (glaucoma).
- Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Active Lyrica (pregabalin) Active drug Placebo placebo placebo comparator
- Primary Outcome Measures
Name Time Method 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 Baseline, Week 12 or Early Termination (any time up to Week 12) 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
Name Time Method 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) 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 Baseline, Week 12 or Early Termination (any time up to Week 12) 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.
Trial Locations
- Locations (149)
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Piedmont Eye Associates
🇺🇸Spartanburg, South Carolina, United States
Office of Robert Snyder, MD
🇺🇸Tucson, Arizona, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
NEA Baptst Clinic
🇺🇸Jonesboro, Arkansas, United States
Premier Neurology, PC
🇺🇸Greer, South Carolina, United States
Glaucoma Consultants and Center for Eye Research, PA
🇺🇸Mount Pleasant, South Carolina, United States
M.S. Ramaiah Medical College and Hospitals,
🇮🇳Bangalore,, Karnataka, India
Budapest Retina Associates Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
King George Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
Netra Diagnostics (P) Ltd
🇮🇳Abids, Hyderabad, Andhra Pradesh, India
Kasturba Medical College and Hospital,
🇮🇳Manipal, Karnataka, India
Dr. Ram Manohar Lohia Hospital
🇮🇳New Delhi, India
Egret Bay Neurology, PA
🇺🇸Houston, Texas, United States
Pharmax Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Neurology Center of Las Vegas
🇺🇸Las Vegas, Nevada, United States
Neurology Center, P.C.
🇺🇸Mobile, Alabama, United States
Premier Medical Group
🇺🇸Mobile, Alabama, United States
Neurology Clinic, PC
🇺🇸Northport, Alabama, United States
North River Ophthalmology
🇺🇸Tuscaloosa, Alabama, United States
Western Neurosurgery
🇺🇸Tucson, Arizona, United States
REM Medical Clinical Research
🇺🇸Tucson, Arizona, United States
NEA Baptist Clinic - Clinical Research Center
🇺🇸Jonesboro, Arkansas, United States
Chenal MRI
🇺🇸Little Rock, Arkansas, United States
Radiology Consultants
🇺🇸Little Rock, Arkansas, United States
Eye Care Arkansas
🇺🇸Little Rock, Arkansas, United States
Mireille P. Hamparian
🇺🇸Glendale, California, United States
Barbara Swartz, MD, Inc
🇺🇸Costa Mesa, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Lakeside Vision Center
🇺🇸Irvine, California, United States
Clinical Innovations, Inc.
🇺🇸Paramount, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Bradenton Research Center, Inc
🇺🇸Bradenton, Florida, United States
The Eye Associates
🇺🇸Bradenton, Florida, United States
Dr. Raul F. Masvidal, MD, PA
🇺🇸Miami, Florida, United States
White Wilson Medical Center
🇺🇸Fort Walton Beach, Florida, United States
SJS Clinical Research, Inc.
🇺🇸Destin, Florida, United States
David M Klein, MD, PA
🇺🇸Port Charlotte, Florida, United States
Medsol Clinical Research Center, Inc
🇺🇸Port Charlotte, Florida, United States
Intercoastal Medical Research Center
🇺🇸Sarasota, Florida, United States
Dr. Nicholas Monsul
🇺🇸Sarasota, Florida, United States
Sarasota Retinal Institute
🇺🇸Sarasota, Florida, United States
Coastal Research Associates, LLC
🇺🇸Atlanta, Georgia, United States
Comprehensive Neurology Specialists, PC
🇺🇸Suwanee, Georgia, United States
Louisiana Eye and Laser Center
🇺🇸Alexandria, Louisiana, United States
Neuromedical Clinic of Central Louisiana
🇺🇸Alexandria, Louisiana, United States
University of Maryland Eye Associates, P.A.
🇺🇸Baltimore, Maryland, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Center for Brain and Neuro Care, LLC
🇺🇸Fulton, Maryland, United States
Glaucoma Plus Eye Care, LLC
🇺🇸Columbia, Maryland, United States
The Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Bergman Eye Associates
🇺🇸Hagerstown, Maryland, United States
Neurology Consultant, P.A.
🇺🇸Hagerstown, Maryland, United States
Coastal Eye Associates
🇺🇸Webster, Texas, United States
Otdelenie po nervni bolesti, MBAL Doverie
🇧🇬Sofia, Bulgaria
NEUROPS s.r.o.
🇨🇿Rychnov nad Kneznou, Czechia
Vitreo-Retinal Consultants and Surgeons
🇺🇸Wichita, Kansas, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Dr. Ruben Munoz Flores de la Torre Ophthalmic Office
🇲🇽Aquascalientes, Mexico
NZOZ Tommed
🇵🇱Katowice, Poland
Harper Hospital
🇺🇸Detroit, Michigan, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Office of Patricia Burke, MD
🇺🇸Paramus, New Jersey, United States
CCN-MS & Neurology Associates
🇺🇸Columbia, Missouri, United States
Nevada Eye Care
🇺🇸Las Vegas, Nevada, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Digby Eye Associates
🇺🇸Greensboro, North Carolina, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Fraser Eye Care Center
🇺🇸Fraser, Michigan, United States
Institute of Neurological Care
🇺🇸Englewood Cliffs, New Jersey, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Daniel J. Nadler, MD, PC
🇺🇸Beaver, Pennsylvania, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Jeffrey Shaver, MD
🇺🇸Edmond, Oklahoma, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Center For Advanced Eye Care
🇺🇸Greenville, South Carolina, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Pacific Women's Center, LLC
🇺🇸Eugene, Oregon, United States
Envision Eye Care
🇺🇸Bristol, Tennessee, United States
Valley Neurological Associates
🇺🇸Monaca, Pennsylvania, United States
Neurology Centers of the Carolinas
🇺🇸Spartanburg, South Carolina, United States
Tidewater Neurology
🇺🇸Mount Pleasant, South Carolina, United States
Tri-state Mountain Neurology Associates, PC
🇺🇸Johnson City, Tennessee, United States
Chetvarta nevrologichna klinika
🇧🇬Sofia, Bulgaria
DKC 2
🇧🇬Sofia, Bulgaria
Ocni ambulance
🇨🇿Rychnov nad Kneznou, Czechia
Otdelenie po Nevrologia, Vtora MBAL
🇧🇬Sofia, Bulgaria
Krishna Institute of Medical Sciences Ltd.
🇮🇳Secunderabad, Andhra Pradesh, India
St. John's Medical College Hospital
🇮🇳Bangalore, Karnataka, India
Mallikatta Neuro Center
🇮🇳Mangalore, Karnataka, India
NZOZ Centrum Leczenia Padaczki i Migreny
🇵🇱Krakow, Poland
Sahyadri Clinical Research Development Centre, A unit of Sahyadri Hospitals Ltd,
🇮🇳Pune, Maharashtra, India
Yashoda Hospital
🇮🇳Hyderabad, Telangana, India
Otdelenie po nevrologia, MBAL "Tokuda Bolnitsa"
🇧🇬Sofia, Bulgaria
Universitetska mnogoprofilna bolnitsa za aktivno lechenieAleksandrovska, Klinika po Nevrologia
🇧🇬Sofia, Bulgaria
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako,
ðŸ‡ðŸ‡ºHodmezovasarhely, Hungary
Fakultni Thomayerova nemocnice
🇨🇿Praha 4, Czechia
Kelkar Nursing Home
🇮🇳Pune, Maharashtra, India
M.G.M. Medical College & M. Y. Hospitals,
🇮🇳Indore, Madhya Pradesh, India
Vijaya Health Centre
🇮🇳Chennai, Tamil NADU, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳New Delhi, India
T.N.M.C and B.Y.L Nair Charitable Hospital,
🇮🇳Mumbai, Maharashtra, India
Sahyadri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Yonsei University Health System Severance Hospital
🇰🇷Seoul, Korea, Republic of
Niepubliczny Zaklad Opieki Zdrowotnej "OKOmed" s.c.
🇵🇱Goczalkowice Zdroj, Poland
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Instituto Biomedico de Investigacion AC
🇲🇽Aguascalientes, Aquascalientes, Mexico
Phramongkutklao hospital,
🇹ðŸ‡Bangkok, Thailand
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
🇹ðŸ‡Muang, Khon Kaen, Thailand
Hospital Central Dr. Ignacio Morones Prieto
🇲🇽San Luis Potosi, Mexico
Centrum Medyczne Dendryt
🇵🇱Katowice, Poland
Prywatny Gabinet Okulistyczny dr. n.med. Teresa Gedliczka
🇵🇱Krakow, Poland
Prywatny Gabinet Psychiatryczny dr Ewa Dereszak-Kozanecka
🇵🇱Krakow, Poland
Western New York Ophthalmology Group
🇺🇸Amherst, New York, United States
The Jacobs Neurological Institute Comprehensive Epilepsy Center
🇺🇸Buffalo, New York, United States
Minneapolis Clinic of Neurology, Ltd
🇺🇸Golden Valley, Minnesota, United States
Oregon Eye Consultants, LLC
🇺🇸Eugene, Oregon, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Texan Eye
🇺🇸Austin, Texas, United States
DeHaven Eye Clinic
🇺🇸Longview, Texas, United States
Diagnostic Clinic of Longview Center for Clinical Research
🇺🇸Longview, Texas, United States
Diagnostic Clinic of Longview, PA
🇺🇸Longview, Texas, United States
Heritage Valley Health System
🇺🇸Beaver, Pennsylvania, United States
Synexus Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Orszagos Idegtudomanyi Intezet, Stroke es Epilepszia Osztaly
ðŸ‡ðŸ‡ºBudapest, Hungary
Orszagos Idegtudomanyi Intezet
ðŸ‡ðŸ‡ºBudapest, Hungary
Eye Site,
🇮🇳Indore, Madhya Pradesh, India
Guilford Neurologic Associates, Inc
🇺🇸Greensboro, North Carolina, United States
Eye Treatment Center, Inc.
🇺🇸Long Beach, California, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Oregon Neurology Associates
🇺🇸Springfield, Oregon, United States
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Clinical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Salem Neurological Center, PA
🇺🇸Winston-Salem, North Carolina, United States
Office of Dr. James D. Branch, MD
🇺🇸Winston-Salem, North Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Neurological Associates Sarah Cannon Cancer Institute;
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin Department of Neurology Froedtert Memorial Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin Eye Institute
🇺🇸Milwaukee, Wisconsin, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Semmes Murphey Clinic
🇺🇸Memphis, Tennessee, United States