A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

NCT ID: NCT01463306

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-21
• Study Completion Date: 2019-08-22

Brief Summary

Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.

Conditions

Epilepsy, Partial Seizures; Epilepsy, Primary Generalized Tonic-Clonic Seizures

Study Design

• Allocation Method: NA
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open

Pregabalin open label flexible dose

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.

Interventions

Pregabalin

Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.

Intervention Type: DRUG

Other Intervention Names

Lyrica

Eligibility Criteria

Inclusion Criteria

• Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.
• Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
• Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
• Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
• Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria

• Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
• A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
• Status epilepticus within 1 year prior to visit 1.
• Seizures related to drugs, alcohol, or acute medical illness.
• Progressive structural CNS lesion or a progressive encephalopathy.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Center for Neurosciences

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Axcess Medical Research

Loxahatchee Groves, Florida, United States

Laszlo J. Mate, M.D., P.A.

North Palm Beach, Florida, United States

Pediatric Epilepsy Center Of Central Florida

Orlando, Florida, United States

Pediatric Neurology, PA

Orlando, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Pediatric Epilepsy and Neurology Specialists, PA

Tampa, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Josephson Wallack Munshower Neurology P.C.

Indianapolis, Indiana, United States

Kosair Children's Hospital

Louisville, Kentucky, United States

University of Louisville Physicians

Louisville, Kentucky, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Akron Children's Hospital

Akron, Ohio, United States

Ohio Clinical Research Partners, LLC

Canton, Ohio, United States

The children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Dallas Pediatric Neurology Associates

Dallas, Texas, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

GU Republican Scientific and Practical Center Mother and Child

Minsk, , Belarus

UZ Vitebsk Regional Childrens Clinical Centre

Vitebsk, , Belarus

UZ Vitebsk Regional Childrens Clinical Centre

Vitebsk, , Belarus

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, Brussels Capital, Belgium

Hospital Erasme

Brussels, Brussels Capital, Belgium

UZ Brussel - Campus Jette - Pediatric Neurology

Brussels, Brussels Capital, Belgium

University Clinical Center Sarajevo

Sarajevo, Canton Sarajevo, Bosnia and Herzegovina, Bosnia and Herzegovina

University Clinical Hospital Mostar

Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina

Public Health Institution Hospital "Dr. Mladen Stojanovic"

Prijedor, Republika Srpska, Bosnia and Herzegovina

"Multiprofile Hospital for Active Treatment Puls" AD

Blagoevgrad, , Bulgaria

UMHAT Dr. Georgi Stranski Ltd.

Pleven, , Bulgaria

MHAT Central Onco Hospital OOD

Plovdiv, , Bulgaria

UMHAT "Sveti Georgi" Ltd., Pediatric Clinic

Plovdiv, , Bulgaria

MHATNP Sveti Naum EAD

Sofia, , Bulgaria

DCC Sveta Anna - Sofia\ Neurological room

Sofia, , Bulgaria

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Fakultni nemocnice Brno - Detska nemocnice

Brno - Cerna Pole, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Hopital Raymond Poincare

Garches, , France

CHRU de Rennes - Hopital Pontchaillou

Rennes, , France

Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

Strasbourg, , France

Universitaetsklinikum Jena

Jena, Thuringia, Germany

General Children's Hospital of Athens "P&A Kyriakou"

Athens, , Greece

General Children's Hospital Penteli

Athens, , Greece

Dr. Kenessey Albert Kórház és Rendelőintézet

Balassagyarmat, , Hungary

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/

Budapest, , Hungary

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, , Hungary

Szent Margit Korhaz

Budapest, , Hungary

Heim Pal Gyermekkorhaz, Neurologiai Osztaly

Budapest, , Hungary

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

Budapest, , Hungary

Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly

Kistarcsa, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Mangala Hospital & Mangala Kidney Foundation

Mangalore, Karnataka, India

Getwell Hospital and Research Institute

Dhantoli, Nagpur, Maharashtra, India

KEM Hospital Research Centre

Pune, Maharashtra, India

Bnai Zion Medical Center

Haifa, , Israel

Pharmacy of Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia

Ancona, , Italy

A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi

Ancona, , Italy

Azienda Ospedaliero-Universitaria Meyer

Florence, , Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

Pavia, , Italy

American University of Beirut Medical Center

Beirut, , Lebanon

Saint George Hospital - University Medical Center

Beirut, , Lebanon

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Pzu Neuron

Bijelo Polje, , Montenegro

Cebu Doctors' University Hospital

Cebu City, CEBU, Philippines

Perpetual Succour Hospital

Cebu City, , Philippines

Philippine Children's Medical Center

Diliman, Quezon City, , Philippines

Manila Doctors Hospital

Manila, , Philippines

Metropolitan Medical Center

Manila, , Philippines

University of Santo Tomas Hospital

Manila, , Philippines

Capitol Medical Center Inc.

Quezon City, , Philippines

St. Luke's Medical Center

Quezon City, , Philippines

COPERNICUS Podmiot Leczniczy Sp z o.o.

Gdansk, , Poland

Klinika Neurologii Rozwojowej

Gdansk, , Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

Katowice, , Poland

Nzoz Novo Med

Katowice, , Poland

Gabinet lekarski Neurologii I Leczenia padaczki

Kielce, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.

Krakow, , Poland

Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

Lublin, , Poland

Katedra i Klinika Neurologii Wieku Rozwojowego

Poznan, , Poland

NZOZ "IGNIS" Dr. n. med. Alicja Lobinska

Świdnik, , Poland

Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,

Wroclaw, , Poland

Spitalul clinic de copii Dr. Victor Gomoiu

Bucharest, , Romania

Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

Bucharest, , Romania

Spitalul Clinic de Urgente pentru Copii "Sf. Maria"

Iași, , Romania

Spitalul de Psihiatrie Dr. Ghe. Preda

Sibiu, , Romania

Centrul Medical Dr. Bacos Cosma

Timișoara, , Romania

SPHI Leningrad Regional Psychoneurological Dispensary

Pgt. Roshchino, Leningradskaya Oblast', Russia

Nizhmedklinika

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Perm State Medical University n. a. acad. E.A. Vagner

Perm, Permskiy KRAY, Russia

State Budgetary Healthcare Institution of Stavropol region

Pyatigorsk, Stavropol Kray, Russia

TSBHI City Hospital No. 5 of Barnaul

Barnaul, , Russia

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

Moscow, , Russia

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

Moscow, , Russia

Non-state Healthcare Institution

Moscow, , Russia

Perm State Medical University n. a. acad. E.A. Vagner

Perm, , Russia

LLC Medical Technologies

Saint Petersburg, , Russia

SPHI Leningrad Regional Psychoneurological Dispensary

Saint Petersburg, , Russia

FSBI V.M. Bekhterev National Research Medical Center

Saint Petersburg, , Russia

LLC Medical Technologies

Saint Petersburg, , Russia

SBHI of Saint Petersburg Psychoneurological Dispensary #5

Saint Petersburg, , Russia

SBHI of Saint Petersburg Psychoneurological Dispensary #5

Saint Petersburg, , Russia

Regional State Budgetary Institution of Ministry of Health

Smolensk, , Russia

RSBHI Smolensk Regional Clinical Hospital

Smolensk, , Russia

GBOU VPO "Smolensk State Medical University"

Smolensk, , Russia

MAI Children's City Clinical Hospital No 9

Yekaterinburg, , Russia

Institute for Child and Youth Healthcare of Vojvodina

Novi Sad, Vojvodina, Serbia

Mother and Child Healthcare Institute Dr Vukan Cupic

Belgrade, , Serbia

University Children's Hospital Belgrade

Belgrade, , Serbia

Clinical Center of Kragujevac

Kragujevac, , Serbia

National University Hospital

Singapore, , Singapore

KK Women's and Children's Hospital

Singapore, , Singapore

Neurologicka ambulancia MUDr. Eva Gasparova

Hlohovec, , Slovakia

Seoul National University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Siriraj Hospital, Mahidol University, Faculty of Medicine

Bangkoknoi, Bangkok, Thailand

Phramongkutklao Hospital, Neurology Unit,

Ratchathevee, Bangkok, , Thailand

Hacettepe University Medical Faculty

Ankara, Ankara/sihhiye, Turkey (Türkiye)

Ege University Medical Faculty Department of Pediatrics Health and Diseases,

Izmir, Bornova/izmir, Turkey (Türkiye)

Karadeniz Technical University Faculty of Medicine Farabi Hospital

Trabzon, Farabi, Turkey (Türkiye)

Izmir Tepecik Training and Research Hospital

Izmir, Konak Turkey, Turkey (Türkiye)

Behcet Uz Children Disease and Surgery Training and Research Hospital

Izmir, Konak, Turkey (Türkiye)

Eskisehir Osmangazi University Medical Faculty

Eskişehir, Meselik Campus, Turkey (Türkiye)

Dokuz Eylül University medical Faculty Internal Medicine Disease

Izmir, , Turkey (Türkiye)

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"

Dnipro, , Ukraine

Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

Dnipropetrovsk, , Ukraine

Ivano-Frankivska oblasna dytiacha klinichna likarnia

Ivano-Frankivsk, , Ukraine

Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

Kharkiv, , Ukraine

Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li

Kharkiv, , Ukraine

Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam

Kyiv, , Ukraine

Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv

Lviv, , Ukraine

Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

Odesa, , Ukraine

Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"

Odesa, , Ukraine

KU "Odeska oblasna dytiacha klinichna likarnia"

Odesa, , Ukraine

Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"

S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl., , Ukraine

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2

Uzhhorod, , Ukraine

Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia

Zaporizhzhia, , Ukraine

The Barberry National Centre for Mental Health

Birmingham, WEST Midlands, United Kingdom

Salford Royal NHS Foundation Trust

Salford, , United Kingdom

Countries

United States; Belarus; Belgium; Bosnia and Herzegovina; Bulgaria; China; Czechia; France; Germany; Greece; Hungary; India; Israel; Italy; Lebanon; Malaysia; Montenegro; Philippines; Poland; Romania; Russia; Serbia; Singapore; Slovakia; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pility%20Of%20Pregabages/landing.aspx?StudyID=A0081106

To obtain contact information for a study center near you, click here.

Other Identifiers

2011-001412-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A0081106

Identifier Type: -

Identifier Source: org_study_id