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Epilepsies, PartialPhase 4NCT00351611

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

A Phase 4 study testing Lyrica (pregabalin) in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 150 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epilepsies, Partial
What is being tested?
Lyrica (pregabalin)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
150 sitesin 9 countries
Study dates
26 Jul 2006to 4 Feb 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Epilepsy partial seizure subjects.
  • Currently taking 1 to 3 antiepileptic drugs.

Who cannot join

  • Pre-existing eye diseases (glaucoma).
  • Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.

Trial locations and contacts

150 sites in 9 countries.

150 sites in 9 countries

United States103 sites

  • Neuromedical Clinic of Central Louisiana

    Alexandria, Louisiana, 71301

  • Louisiana Eye and Laser Center

    Alexandria, Louisiana, 71303

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Western New York Ophthalmology Group

    Amherst, New York, 14226

  • Coastal Research Associates, LLC

    Atlanta, Georgia, 30339

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Texan Eye

    Austin, Texas, 78731

  • University of Maryland Eye Associates, P.A.

    Baltimore, Maryland, 21201

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Maryland

    Baltimore, Maryland, 21201

  • Daniel J. Nadler, MD, PC

    Beaver, Pennsylvania, 15009

  • Heritage Valley Health System

    Beaver, Pennsylvania, 15009

  • Bradenton Research Center, Inc

    Bradenton, Florida, 34205

  • The Eye Associates

    Bradenton, Florida, 34209

  • Envision Eye Care

    Bristol, Tennessee, 37620

  • Buffalo General Hospital

    Buffalo, New York, 14203

  • The Jacobs Neurological Institute Comprehensive Epilepsy Center

    Buffalo, New York, 14209

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Glaucoma Plus Eye Care, LLC

    Columbia, Maryland, 21044

  • University of Missouri

    Columbia, Missouri, 65212

  • CCN-MS & Neurology Associates

    Columbia, Missouri, 65401

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Barbara Swartz, MD, Inc

    Costa Mesa, California, 92627

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • Glaucoma Associates of Texas

    Dallas, Texas, 75231

  • SJS Clinical Research, Inc.

    Destin, Florida, 32541

  • Harper Hospital

    Detroit, Michigan, 48201

  • Wayne State University

    Detroit, Michigan, 48201

  • Jeffrey Shaver, MD

    Edmond, Oklahoma, 73013

  • Institute of Neurological Care

    Englewood Cliffs, New Jersey, 07632

  • Clinical Trials of America, Inc.

    Eugene, Oregon, 97401

  • Oregon Eye Consultants, LLC

    Eugene, Oregon, 97401

  • Pacific Women's Center, LLC

    Eugene, Oregon, 97401

  • White Wilson Medical Center

    Fort Walton Beach, Florida, 32547

  • Fraser Eye Care Center

    Fraser, Michigan, 48026

  • Center for Brain and Neuro Care, LLC

    Fulton, Maryland, 20759

  • Mireille P. Hamparian

    Glendale, California, 91206

  • Minneapolis Clinic of Neurology, Ltd

    Golden Valley, Minnesota, 55422

  • Guilford Neurologic Associates, Inc

    Greensboro, North Carolina, 27405

  • Digby Eye Associates

    Greensboro, North Carolina, 27408

  • Center For Advanced Eye Care

    Greenville, South Carolina, 29615

  • Premier Neurology, PC

    Greer, South Carolina, 29650

  • Bergman Eye Associates

    Hagerstown, Maryland, 21740

  • Neurology Consultant, P.A.

    Hagerstown, Maryland, 21740

  • The Center for Clinical Research

    Hagerstown, Maryland, 21740

  • Egret Bay Neurology, PA

    Houston, Texas, 77058

  • Lakeside Vision Center

    Irvine, California, 92604

  • Tri-state Mountain Neurology Associates, PC

    Johnson City, Tennessee, 37604

  • NEA Baptist Clinic - Clinical Research Center

    Jonesboro, Arkansas, 72401

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • NEA Baptst Clinic

    Jonesboro, Arkansas, 72401

  • Nevada Eye Care

    Las Vegas, Nevada, 89119

  • Neurology Center of Las Vegas

    Las Vegas, Nevada, 89128

  • Chenal MRI

    Little Rock, Arkansas, 72205

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Eye Care Arkansas

    Little Rock, Arkansas, 72205

  • Radiology Consultants

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Eye Treatment Center, Inc.

    Long Beach, California, 90813

  • DeHaven Eye Clinic

    Longview, Texas, 75601

  • Diagnostic Clinic of Longview Center for Clinical Research

    Longview, Texas, 75605

  • Diagnostic Clinic of Longview, PA

    Longview, Texas, 75605

  • Semmes Murphey Clinic

    Memphis, Tennessee, 38104

  • Semmes Murphey Clinic

    Memphis, Tennessee, 38120

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Pharmax Research Clinic, Inc.

    Miami, Florida, 33126

  • Dr. Raul F. Masvidal, MD, PA

    Miami, Florida, 33134

  • Medical College of Wisconsin Department of Neurology Froedtert Memorial Hospital

    Milwaukee, Wisconsin, 53226-3522

  • Medical College of Wisconsin Eye Institute

    Milwaukee, Wisconsin, 53226

  • Neurology Center, P.C.

    Mobile, Alabama, 36607

  • Premier Medical Group

    Mobile, Alabama, 36608

  • Valley Neurological Associates

    Monaca, Pennsylvania, 15061

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Glaucoma Consultants and Center for Eye Research, PA

    Mt. Pleasant, South Carolina, 29464

  • Tidewater Neurology

    Mt. Pleasant, South Carolina, 29464

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8018

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Neurology Clinic, PC

    Northport, Alabama, 35476

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Innovations, Inc.

    Paramount, California, 90723

  • Office of Patricia Burke, MD

    Paramus, New Jersey, 07652

  • David M Klein, MD, PA

    Port Charlotte, Florida, 33948

  • Medsol Clinical Research Center, Inc

    Port Charlotte, Florida, 33952

  • Neurological Associates Sarah Cannon Cancer Institute;

    Richmond, Virginia, 23229

  • Intercoastal Medical Research Center

    Sarasota, Florida, 34232

  • Dr. Nicholas Monsul

    Sarasota, Florida, 34239

  • Sarasota Retinal Institute

    Sarasota, Florida, 34239

  • Neurology Centers of the Carolinas

    Spartanburg, South Carolina, 29302

  • Piedmont Eye Associates

    Spartanburg, South Carolina, 29303

  • Oregon Neurology Associates

    Springfield, Oregon, 97477

  • Comprehensive Neurology Specialists, PC

    Suwanee, Georgia, 30024

  • Western Neurosurgery

    Tucson, Arizona, 85710

  • Office of Robert Snyder, MD

    Tucson, Arizona, 85712

  • REM Medical Clinical Research

    Tucson, Arizona, 85712

  • North River Ophthalmology

    Tuscaloosa, Alabama, 35406

  • Coastal Eye Associates

    Webster, Texas, 77598

  • Professional Research Network of Kansas

    Wichita, Kansas, 67203

  • Vitreo-Retinal Consultants and Surgeons

    Wichita, Kansas, 67214

  • Clinical Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Salem Neurological Center, PA

    Winston-Salem, North Carolina, 27103

  • Office of Dr. James D. Branch, MD

    Winston-Salem, North Carolina, 27107

Other trials in United States

India17 sites

  • Netra Diagnostics (P) Ltd

    Abids, Hyderabad, Andhra Pradesh, 500 001

  • St. John's Medical College Hospital

    Bangalore, Karnataka, 560034

  • M.S. Ramaiah Medical College and Hospitals,

    Bangalore, Karnataka, 560054

  • Vijaya Health Centre

    Chennai, Tamil Nadu, 600 026

  • Yashoda Hospital

    Hyderabad, Telangana, 500 082

  • Eye Site,

    Indore, Madhya Pradesh, 452 001

  • M.G.M. Medical College & M. Y. Hospitals,

    Indore, Madhya Pradesh, 452 001

  • Mallikatta Neuro Center

    Mangalore, Karnataka, 575002

  • Kasturba Medical College and Hospital,

    Manipal, Karnataka, 576 104

  • T.N.M.C and B.Y.L Nair Charitable Hospital,

    Mumbai, Maharashtra, 400 008

  • Dr. Ram Manohar Lohia Hospital

    New Delhi, 110 001

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029

  • Kelkar Nursing Home

    Pune, Maharashtra, 411004

  • Sahyadri Clinical Research Development Centre, A unit of Sahyadri Hospitals Ltd,

    Pune, Maharashtra, 411004

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • Krishna Institute of Medical Sciences Ltd.

    Secunderabad, Andhra Pradesh, 500 003

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Bulgaria6 sites

  • DKC 2

    Sofia, 1000

  • Chetvarta nevrologichna klinika

    Sofia, 1113

  • Otdelenie po Nevrologia, Vtora MBAL

    Sofia, 1202

  • Otdelenie po nevrologia, MBAL "Tokuda Bolnitsa"

    Sofia, 1407

  • Universitetska mnogoprofilna bolnitsa za aktivno lechenieAleksandrovska, Klinika po Nevrologia

    Sofia, 1431

  • Otdelenie po nervni bolesti, MBAL Doverie

    Sofia, 1632

Other trials in Bulgaria

Poland6 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej "OKOmed" s.c.

    Goczałkowice Zdrój, 43-230

  • NZOZ Tommed

    Katowice, 40-662

  • Centrum Medyczne Dendryt

    Katowice, 40-683

  • Prywatny Gabinet Psychiatryczny dr Ewa Dereszak-Kozanecka

    Krakow, 30-040

  • Prywatny Gabinet Okulistyczny dr. n.med. Teresa Gedliczka

    Krakow, 30-319

  • NZOZ Centrum Leczenia Padaczki i Migreny

    Krakow, 31-209

Other trials in Poland

Hungary5 sites

  • Synexus Kft.

    Budapest, 1036

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Orszagos Idegtudomanyi Intezet, Stroke es Epilepszia Osztaly

    Budapest, 1145

  • Orszagos Idegtudomanyi Intezet

    Budapest, 1145

  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako,

    Hódmezővásárhely, 6800

Other trials in Hungary

South Korea5 sites

  • Keimyung University Dongsan Hospital

    Daegu, 41931

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Health System Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Czechia3 sites

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

  • NEUROPS s.r.o.

    Rychnov nad Kněžnou, 516 01

  • Ocni ambulance

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Mexico3 sites

  • Instituto Biomedico de Investigacion AC

    Aguascalientes, Aquascalientes, 20127

  • Dr. Ruben Munoz Flores de la Torre Ophthalmic Office

    Aquascalientes, Aquascalientes, 20000

  • Hospital Central Dr. Ignacio Morones Prieto

    San Luis Potosí City, 78240

Other trials in Mexico

Thailand2 sites

  • Phramongkutklao hospital,

    Bangkok, 10400

  • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine

    Muang, Changwat Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: 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.

Being tested
Lyrica (pregabalin), placebo
Keywords
epilepsy partial seizure treatment with pregabalin or placebo, vision testing
Medical subject headings
Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lyrica (pregabalin)Drug

    150 mg twice a day, oral administration

  • placeboDrug

    Twice a day, oral administration

Study groups in NCT00351611
Study groupRoleWhat they receive
ActiveExperimentalActive drug
Receives: Drug: Lyrica (pregabalin)
PlaceboPlacebo comparatorplacebo comparator
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 12 or Early Termination (any time up to Week 12)

Secondary outcomes (2)

  1. 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.

    Measured: Baseline, Week 12 or Early Termination (any time up to Week 12)

  2. 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.

    Measured: Baseline, Week 12 or Early Termination (any time up to Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2006 (estimated)
  2. Study start26 Jul 2006
  3. Primary completion4 Feb 2020
  4. Study completion4 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351611
Sponsor's protocol ID
A0081096
Other IDs
2009-014269-25, 2009
Status last verified
Apr 2021
First submitted
11 Jul 2006
Last updated
13 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lyrica (pregabalin) in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 150 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, India, Bulgaria, Poland, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline, Week 12 or Early Termination (any time up to Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00351611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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