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NCT00351611 Clinical Trial

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

Epilepsies, Partial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00351611
Other study ID # A0081096
Secondary ID 2009-014269-25
Status Completed
Phase Phase 4
First received
Last updated
Start date July 26, 2006
Est. completion date February 4, 2020

Study information
Verified date April 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date February 4, 2020
Est. primary completion date February 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lyrica (pregabalin)
150 mg twice a day, oral administration
• placebo
Twice a day, oral administration

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  India,  Korea, Republic of,  Mexico,  Poland,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
See also
  Status Clinical Trial Phase
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Completed NCT00143143 - Pregabalin Open-Label Extension Trial in Patients With Partial Seizures Phase 3
Completed NCT00771927 - Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures N/A
Completed NCT00236873 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. Phase 2
Completed NCT01745952 - Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS) N/A
Completed NCT00772603 - Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures Phase 3
Completed NCT00280696 - A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures Phase 3
Completed NCT00643136 - A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures Phase 3
Completed NCT00230698 - A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure Phase 3
Completed NCT00072813 - MRI in Autosomal Dominant Partial Epilepsy With Auditory Features N/A
Enrolling by invitation NCT04309812 - Transcranial Direct Current to Treat Epilepsy at Home Early Phase 1
Withdrawn NCT00422110 - A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures Phase 2/Phase 3
Completed NCT00620555 - A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures Phase 3
Completed NCT00448916 - Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures Phase 3
Completed NCT00210522 - An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy Phase 2
Completed NCT00236886 - Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients Phase 3
Completed NCT00236860 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures Phase 2
Active, not recruiting NCT03689114 - Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) Phase 4
Completed NCT01098162 - Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug N/A
Completed NCT05273398 - Effects of Diazepam on RNS Detections Phase 4

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