Clinical trial NCT00351611: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsies, Partial
Keywords: epilepsy partial seizure treatment with pregabalin or placebo
vision testing
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 12 or Early Termination (any time up to Week 12)
Secondary outcomes:
measure: Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination
timeFrame: Baseline, Week 12 or Early Termination (any time up to Week 12)
measure: Change From Baseline in Visual Acuity at Week 12 or Early Termination
timeFrame: Baseline, Week 12 or Early Termination (any time up to Week 12)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Neurology Center, P.C.
state: Alabama
city: Mobile
country: United States
facility: Premier Medical Group
state: Alabama
city: Northport
country: United States
facility: Neurology Clinic, PC
state: Alabama
city: Tuscaloosa
country: United States
facility: North River Ophthalmology
state: Alabama
city: Tucson
country: United States
facility: Western Neurosurgery
state: Arizona
city: Tucson
country: United States
facility: Office of Robert Snyder, MD
state: Arizona
city: Tucson
country: United States
facility: REM Medical Clinical Research
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic - Clinical Research Center
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptst Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Chenal MRI
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Eye Care Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Radiology Consultants
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Costa Mesa
country: United States
facility: Barbara Swartz, MD, Inc
state: California
city: Glendale
country: United States
facility: Mireille P. Hamparian
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center
state: California
city: Long Beach
country: United States
facility: Eye Treatment Center, Inc.
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Paramount
country: United States
facility: Clinical Innovations, Inc.
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc
state: Florida
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Fort Walton Beach
country: United States
facility: White Wilson Medical Center
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Dr. Raul F. Masvidal, MD, PA
state: Florida
city: Port Charlotte
country: United States
facility: David M Klein, MD, PA
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center, Inc
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Research Center
state: Florida
city: Sarasota
country: United States
facility: Dr. Nicholas Monsul
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retinal Institute
state: Florida
city: Atlanta
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Suwanee
country: United States
facility: Comprehensive Neurology Specialists, PC
state: Georgia
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Wichita
country: United States
facility: Vitreo-Retinal Consultants and Surgeons
state: Kansas
city: Alexandria
country: United States
facility: Neuromedical Clinic of Central Louisiana
state: Louisiana
city: Alexandria
country: United States
facility: Louisiana Eye and Laser Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Eye Associates, P.A.
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Columbia
country: United States
facility: Glaucoma Plus Eye Care, LLC
state: Maryland
city: Fulton
country: United States
facility: Center for Brain and Neuro Care, LLC
state: Maryland
city: Hagerstown
country: United States
facility: Bergman Eye Associates
state: Maryland
city: Hagerstown
country: United States
facility: Neurology Consultant, P.A.
state: Maryland
city: Hagerstown
country: United States
facility: The Center for Clinical Research
state: Maryland
city: Detroit
country: United States
facility: Harper Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology, Ltd
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Columbia
country: United States
facility: CCN-MS & Neurology Associates
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Eye Care
state: Nevada
city: Las Vegas
country: United States
facility: Neurology Center of Las Vegas
state: Nevada
city: Englewood Cliffs
country: United States
facility: Institute of Neurological Care
state: New Jersey
city: Paramus
country: United States
facility: Office of Patricia Burke, MD
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Amherst
country: United States
facility: Western New York Ophthalmology Group
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: Buffalo
country: United States
facility: The Jacobs Neurological Institute Comprehensive Epilepsy Center
state: New York
city: Greensboro
country: United States
facility: Guilford Neurologic Associates, Inc
state: North Carolina
city: Greensboro
country: United States
facility: Digby Eye Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Salem Neurological Center, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Office of Dr. James D. Branch, MD
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Edmond
country: United States
facility: Jeffrey Shaver, MD
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Eugene
country: United States
facility: Oregon Eye Consultants, LLC
state: Oregon
city: Eugene
country: United States
facility: Pacific Women's Center, LLC
state: Oregon
city: Springfield
country: United States
facility: Oregon Neurology Associates
state: Oregon
city: Beaver
country: United States
facility: Daniel J. Nadler, MD, PC
state: Pennsylvania
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Monaca
country: United States
facility: Valley Neurological Associates
state: Pennsylvania
city: Greenville
country: United States
facility: Center For Advanced Eye Care
state: South Carolina
city: Greer
country: United States
facility: Premier Neurology, PC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: Tidewater Neurology
state: South Carolina
city: Spartanburg
country: United States
facility: Neurology Centers of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Piedmont Eye Associates
state: South Carolina
city: Bristol
country: United States
facility: Envision Eye Care
state: Tennessee
city: Johnson City
country: United States
facility: Tri-state Mountain Neurology Associates, PC
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey Clinic
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey Clinic
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Houston
country: United States
facility: Egret Bay Neurology, PA
state: Texas
city: Longview
country: United States
facility: DeHaven Eye Clinic
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview Center for Clinical Research
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview, PA
state: Texas
city: Webster
country: United States
facility: Coastal Eye Associates
state: Texas
city: Richmond
country: United States
facility: Neurological Associates Sarah Cannon Cancer Institute;
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Department of Neurology Froedtert Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Eye Institute
state: Wisconsin
city: Sofia
country: Bulgaria
facility: DKC 2
city: Sofia
country: Bulgaria
facility: Chetvarta nevrologichna klinika
city: Sofia
country: Bulgaria
facility: Otdelenie po Nevrologia, Vtora MBAL
city: Sofia
country: Bulgaria
facility: Otdelenie po nevrologia, MBAL "Tokuda Bolnitsa"
city: Sofia
country: Bulgaria
facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenieAleksandrovska, Klinika po Nevrologia
city: Sofia
country: Bulgaria
facility: Otdelenie po nervni bolesti, MBAL Doverie
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Rychnov nad Kneznou
country: Czechia
facility: NEUROPS s.r.o.
city: Rychnov nad Kneznou
country: Czechia
facility: Ocni ambulance
city: Budapest
country: Hungary
facility: Synexus Kft.
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Budapest
country: Hungary
facility: Orszagos Idegtudomanyi Intezet, Stroke es Epilepszia Osztaly
city: Budapest
country: Hungary
facility: Orszagos Idegtudomanyi Intezet
city: Hodmezovasarhely
country: Hungary
facility: Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako,
city: Abids, Hyderabad
country: India
facility: Netra Diagnostics (P) Ltd
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd.
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Bangalore,
country: India
facility: M.S. Ramaiah Medical College and Hospitals,
state: Karnataka
city: Bangalore
country: India
facility: St. John's Medical College Hospital
state: Karnataka
city: Mangalore
country: India
facility: Mallikatta Neuro Center
state: Karnataka
city: Manipal
country: India
facility: Kasturba Medical College and Hospital,
state: Karnataka
city: Indore
country: India
facility: Eye Site,
state: Madhya Pradesh
city: Indore
country: India
facility: M.G.M. Medical College & M. Y. Hospitals,
state: Madhya Pradesh
city: Mumbai
country: India
facility: T.N.M.C and B.Y.L Nair Charitable Hospital,
state: Maharashtra
city: Pune
country: India
facility: Kelkar Nursing Home
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research Development Centre, A unit of Sahyadri Hospitals Ltd,
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Chennai
country: India
facility: Vijaya Health Centre
state: Tamil NADU
city: Hyderabad
country: India
facility: Yashoda Hospital
state: Telangana
city: New Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Aguascalientes
country: Mexico
facility: Instituto Biomedico de Investigacion AC
state: Aquascalientes
city: Aquascalientes
country: Mexico
facility: Dr. Ruben Munoz Flores de la Torre Ophthalmic Office
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
city: Goczalkowice Zdroj
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "OKOmed" s.c.
city: Katowice
country: Poland
facility: NZOZ Tommed
city: Katowice
country: Poland
facility: Centrum Medyczne Dendryt
city: Krakow
country: Poland
facility: Prywatny Gabinet Psychiatryczny dr Ewa Dereszak-Kozanecka
city: Krakow
country: Poland
facility: Prywatny Gabinet Okulistyczny dr. n.med. Teresa Gedliczka
city: Krakow
country: Poland
facility: NZOZ Centrum Leczenia Padaczki i Migreny
city: Muang
country: Thailand
facility: Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Phramongkutklao hospital,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: