A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

NCT ID: NCT01389596

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-27
• Study Completion Date: 2016-08-10

Brief Summary

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Conditions

Epilepsy, Partial Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Pregabalin add-on therapy

Intervention Type: DRUG

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Pregabalin Level 1 (max 150 mg/day)

Group Type: EXPERIMENTAL

Pregabalin add-on therapy

Intervention Type: DRUG

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Pregabalin Level 2 (max 600 mg day)

Group Type: EXPERIMENTAL

Pregabalin add-on therapy

Intervention Type: DRUG

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Interventions

Pregabalin add-on therapy

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Intervention Type: DRUG

Pregabalin add-on therapy

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Intervention Type: DRUG

Pregabalin add-on therapy

Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
• Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
• Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
• Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
• Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria

• Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.
• Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
• A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
• Status epilepticus within 1 year prior to screening.
• Seizures related to drugs, alcohol, or acute medical illness.
• Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase.
• Progressive structural CNS lesion or a progressive encephalopathy.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 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

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 Neurology, P.A.

Orlando, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Center for Clinical and Translational Science

Lexington, Kentucky, United States

Kentucky Neuroscience Institute

Lexington, Kentucky, United States

University of Kentucky Hospital Epilepsy Monitoring Unit

Lexington, Kentucky, United States

University of Kentucky Hospital Pharmacy, UK Chandler Hosptial

Lexington, Kentucky, United States

Kosair Charities Pediatric Clinical

Louisville, Kentucky, 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

Duke Children's Hospital and Health Center

Durham, North Carolina, United States

Duke Clinical Research Unit

Durham, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Centre Hospitalier Neurologique William Lennox

Ottignies, Brabant Wallon, Belgium

HUDERF

Brussels, Brussels Capital, Belgium

Cliniques Universitaires de Bruxelles Hôpital Erasme

Brussels, , Belgium

UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania

Plovdiv, , Bulgaria

Fakultni nemocnice Brno - Detska nemocnice

Brno - Cerna Pole, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

CHU Bordeaux - Hopital des Enfants

Bordeaux, , France

Hôpital Mère Enfant

Bron, , France

Hopital Raymond Poincare

Garches, , France

Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

Strasbourg, , France

General Childrens Hospital of Athens P & A Kyriakou

Athens, , Greece

General Children's Hospital Penteli

Athens, , Greece

Dr. Kenessey Albert Korhaz es Rendelointezet

Balassagyarmat, , Hungary

Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak

Budapest, , Hungary

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

Budapest, , Hungary

Heim Pal Gyermekkorhaz, Neurologiai Osztaly

Budapest, , Hungary

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

Budapest, , Hungary

Pécsi Tudományegyetem Klinikai Központ

Pécs, , Hungary

Bnai Zion Medical Center

Haifa, , Israel

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 - Servizio di Farmacia

Pavia, , Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

Pavia, , Italy

Paediatric Department

Ipoh, Perak, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Cebu Doctors' University Hospital

Cebu City, CEBU, Philippines

Center for Neurodiagnostic and Therapeutic Services

Sta Cruz, Manila, Philippines

Capitol Medical Center Inc.

Quezon City, National Capital Region, Philippines

Cebu Doctors' University Hospital

Cebu City, , Philippines

University of Santo Tomas Hospital

Manila, , Philippines

St. Luke's Medical Center

Quezon City, , Philippines

Philippine Children's Medical Center

Quezon City, , Philippines

Klinika Neurologii Rozwojowej

Gdansk, , Poland

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, , Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

Krakow, , Poland

Katedra i Klinika Neurologii Wieku Rozwojowego

Poznan, , 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

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

Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Ege University Medical Faculty Department of Pediatrics Health and Diseases

Izmir, Bornova, Turkey (Türkiye)

Karadeniz Technical University Faculty of Medicine Farabi Hospital

Trabzon, Farabi, Turkey (Türkiye)

Izmir Tepecik Training and Research Hospital

Izmir, Konak, Turkey (Türkiye)

Behcet Uz Children Disease and surgery Training and research hospital

Izmir, Konak, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Sihhiye/ankara, Turkey (Türkiye)

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia

Dnipropetrovsk, , Ukraine

Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

Dnipropetrovsk, , Ukraine

Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

Kharkiv, , Ukraine

Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,

Kharkiv, , Ukraine

Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

Kyiv, , Ukraine

Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",

Odesa, , Ukraine

Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi

Odesa, , Ukraine

Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",

S. Oleksandrivka, , Ukraine

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,

Uzhhorod, , Ukraine

Countries

United States; Belgium; Bulgaria; Czechia; France; Greece; Hungary; Israel; Italy; Malaysia; Philippines; Poland; Romania; Serbia; Singapore; South Korea; Turkey (Türkiye); Ukraine

References

Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27.

Reference Type: DERIVED

PMID: 30688135 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081041&StudyName=A%20Study%20of%20the%20Efficacy%20and%20Safety%20of%20Pregabalin%20as%20Add-On%20Therapy%20for%20Partial%20Onset%20Seizures%20in%20Children%20Ages%204-16%20Years

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Other Identifiers

2010-020852-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XALCORY 1014

Identifier Type: OTHER

Identifier Source: secondary_id

A0081041

Identifier Type: -

Identifier Source: org_study_id