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

NCT01389596 | Completed Phase 3 Results DMC

• 3 other identifiers: A00810412010-020852-79XALCORY 1014
• Study Type: interventional
• Target: 295
• Locations: 18 countries
• Sites: 86

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

Keywords

safety; efficacy; partial onset seizures; pediatric; pregabalin; placebo-controlled; double-blind

Outcome Measures

Primary Outcomes (2)

• Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase

  All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

  Baseline phase (up to 8 weeks prior to treatment phase [Day 1])

• Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase

  All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

  Day 1 up to Week 12

Secondary Outcomes (1)

• Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase

  Day 1 up to Week 12

Other Outcomes (15)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

• Number of Adverse Events by Severity

  Day 1 up to 7 days after last dose of study drug (up to 13 weeks)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Pregabalin add-on therapy

Pregabalin Level 1 (max 150 mg/day)

EXPERIMENTAL

Drug: Pregabalin add-on therapy

Pregabalin Level 2 (max 600 mg day)

EXPERIMENTAL

Drug: Pregabalin add-on therapy

Interventions

Pregabalin add-on therapy 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.

Placebo

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (86)

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children´s Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Axcess Medical Research

Loxahatchee Groves, Florida, 33470, United States

Location

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

North Palm Beach, Florida, 33408, United States

Location

Pediatric Neurology, P.A.

Orlando, Florida, 32819, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Center for Clinical and Translational Science

Lexington, Kentucky, 40536, United States

Location

Kentucky Neuroscience Institute

Lexington, Kentucky, 40536, United States

Location

University of Kentucky Hospital Epilepsy Monitoring Unit

Lexington, Kentucky, 40536, United States

Location

University of Kentucky Hospital Pharmacy, UK Chandler Hosptial

Lexington, Kentucky, 40536, United States

Location

Kosair Charities Pediatric Clinical

Louisville, Kentucky, 40202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Physicians

Louisville, Kentucky, 40202, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Duke Children's Hospital and Health Center

Durham, North Carolina, 27710, United States

Location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Road Runner Research, Ltd.

San Antonio, Texas, 78258, United States

Location

Centre Hospitalier Neurologique William Lennox

Ottignies, Brabant Wallon, 1340, Belgium

Location

HUDERF

Brussels, Brussels Capital, 1020, Belgium

Location

Cliniques Universitaires de Bruxelles Hôpital Erasme

Brussels, 1070, Belgium

Location

UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania

Plovdiv, 4000, Bulgaria

Location

Fakultni nemocnice Brno - Detska nemocnice

Brno - Cerna Pole, 613 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

CHU Bordeaux - Hopital des Enfants

Bordeaux, 33076, France

Location

Hôpital Mère Enfant

Bron, 69677, France

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

Strasbourg, 67098, France

Location

General Childrens Hospital of Athens P & A Kyriakou

Athens, 11527, Greece

Location

General Children's Hospital Penteli

Athens, 15236, Greece

Location

Dr. Kenessey Albert Korhaz es Rendelointezet

Balassagyarmat, H-2660, Hungary

Location

Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak

Budapest, H-1023, Hungary

Location

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

Budapest, H-1083, Hungary

Location

Heim Pal Gyermekkorhaz, Neurologiai Osztaly

Budapest, H-1089, Hungary

Location

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

Budapest, H-1146, Hungary

Location

Pécsi Tudományegyetem Klinikai Központ

Pécs, 7623, Hungary

Location

Bnai Zion Medical Center

Haifa, 3104802, Israel

Location

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

Ancona, 60123, Italy

Location

Azienda Ospedaliero-Universitaria Meyer

Florence, 50139, Italy

Location

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia

Pavia, 27100, Italy

Location

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

Pavia, 27100, Italy

Location

Paediatric Department

Ipoh, Perak, 30990, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Cebu Doctors' University Hospital

Cebu City, CEBU, 6000, Philippines

Location

Center for Neurodiagnostic and Therapeutic Services

Sta Cruz, Manila, 1003, Philippines

Location

Capitol Medical Center Inc.

Quezon City, National Capital Region, 1100, Philippines

Location

Cebu Doctors' University Hospital

Cebu City, 6000, Philippines

Location

University of Santo Tomas Hospital

Manila, 1008, Philippines

Location

St. Luke's Medical Center

Quezon City, 1102, Philippines

Location

Philippine Children's Medical Center

Quezon City, 1105, Philippines

Location

Klinika Neurologii Rozwojowej

Gdansk, 80-952, Poland

Location

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, 25316, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

Krakow, 31-503, Poland

Location

Katedra i Klinika Neurologii Wieku Rozwojowego

Poznan, 60-355, Poland

Location

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

Wroclaw, 54-049, Poland

Location

Spitalul clinic de copii Dr. Victor Gomoiu

Bucharest, 022102, Romania

Location

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

Bucharest, 041914, Romania

Location

Spitalul Clinic de Urgente pentru Copii "Sf. Maria",

Iași, 700309, Romania

Location

Spitalul de Psihiatrie Dr. Ghe. Preda

Sibiu, 550 082, Romania

Location

Centrul Medical Dr. Bacos Cosma

Timișoara, 300314, Romania

Location

Institute for Child and Youth Healthcare of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Mother and Child Healthcare Institute Dr Vukan Cupic

Belgrade, 11000, Serbia

Location

University Children's Hospital Belgrade

Belgrade, 11000, Serbia

Location

Clinical Center of Kragujevac

Kragujevac, 34000, Serbia

Location

National University Hospital

Singapore, 119074, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology

Seoul, 06351, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120 752, South Korea

Location

Ege University Medical Faculty Department of Pediatrics Health and Diseases

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Karadeniz Technical University Faculty of Medicine Farabi Hospital

Trabzon, Farabi, 61080, Turkey (Türkiye)

Location

Izmir Tepecik Training and Research Hospital

Izmir, Konak, 35120, Turkey (Türkiye)

Location

Behcet Uz Children Disease and surgery Training and research hospital

Izmir, Konak, 35210, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34890, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, Sihhiye/ankara, 06100, Turkey (Türkiye)

Location

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia

Dnipropetrovsk, 49027, Ukraine

Location

Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

Dnipropetrovsk, 49100, Ukraine

Location

Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

Kharkiv, 61068, Ukraine

Location

Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,

Kharkiv, 61068, Ukraine

Location

Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

Kyiv, 04209, Ukraine

Location

Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",

Odesa, 65006, Ukraine

Location

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

Odesa, 65031, Ukraine

Location

Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",

S. Oleksandrivka, 67513, Ukraine

Location

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,

Uzhhorod, 88018, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 30688135 DERIVED

Related Links

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

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: September 27, 2011
• Primary Completion: August 10, 2016
• Study Completion: August 10, 2016
• Last Updated: January 20, 2021
• Results First Posted: March 21, 2017

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

BU (1); FR (4); CZ (2); SE (4); MY (2); PH (7); PL (5); HU (6); TU (6); RO (5); UA (9); BE (3); GR (2); US (20); IT (4); IL (1); KR (3); SG (2)