A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
- Registration Number
- NCT01389596
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Pregabalin add-on therapy - Pregabalin Level 2 (max 600 mg day) Pregabalin add-on therapy - Pregabalin Level 1 (max 150 mg/day) Pregabalin add-on therapy -
- Primary Outcome Measures
Name Time Method Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) 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).
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase Day 1 up to Week 12 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).
- Secondary Outcome Measures
Name Time Method 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 Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 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.
Trial Locations
- Locations (85)
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Institute for Child and Youth Healthcare of Vojvodina
🇷🇸Novi Sad, Vojvodina, Serbia
Cebu Doctors' University Hospital
🇵🇭Cebu City, Philippines
Klinika Neurologii Rozwojowej
🇵🇱Gdansk, Poland
Center for Neurodiagnostic and Therapeutic Services
🇵🇭Sta. Cruz, Manila, Philippines
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
🇵🇱Krakow, Poland
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka
🇵🇱Wroclaw, Poland
Spitalul clinic de copii Dr. Victor Gomoiu
🇷🇴Bucuresti, Romania
Clinical Center of Kragujevac
🇷🇸Kragujevac, Serbia
Bnai Zion Medical Center
🇮🇱Haifa, Israel
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
🇵🇱Kielce, Poland
Karadeniz Technical University Faculty of Medicine Farabi Hospital
🇹🇷Trabzon, Farabi, Turkey
National University Hospital
🇸🇬Singapore, Singapore
Hacettepe University Medical Faculty
🇹🇷Ankara, Sihhiye/ankara, Turkey
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",
🇺🇦S. Oleksandrivka, Ukraine
Road Runner Research, Ltd.
🇺🇸San Antonio, Texas, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children´s Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Laszlo J. Mate, M.D., P.A.
🇺🇸North Palm Beach, Florida, United States
University of Kentucky Hospital Pharmacy, UK Chandler Hosptial
🇺🇸Lexington, Kentucky, United States
Centre Hospitalier Neurologique William Lennox
🇧🇪Ottignies, Brabant Wallon, Belgium
Cliniques Universitaires de Bruxelles Hôpital Erasme
🇧🇪Brussels, Belgium
General Children's Hospital Penteli
🇬🇷Athens, Greece
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
🇭🇺Budapest, Hungary
Spitalul de Psihiatrie Dr. Ghe. Preda
🇷🇴Sibiu, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
🇷🇴Bucuresti, Romania
University Children's Hospital Belgrade
🇷🇸Belgrade, Serbia
Centrul Medical Dr. Bacos Cosma
🇷🇴Timisoara, Romania
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia
🇺🇦Dnipropetrovsk, Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,
🇺🇦Uzhgorod, Ukraine
Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi
🇺🇦Odesa, Ukraine
Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",
🇺🇦Odesa, Ukraine
A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
🇮🇹Ancona, Italy
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
HUDERF
🇧🇪Brussels, Brussels-capital, Belgium
Dr. Kenessey Albert Korhaz es Rendelointezet
🇭🇺Balassagyarmat, Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
🇭🇺Budapest, Hungary
Hôpital Mère Enfant
🇫🇷Bron, France
Paediatric Department
🇲🇾Ipoh, Perak, Malaysia
Fakultni nemocnice Brno - Detska nemocnice
🇨🇿Brno - Cerna Pole, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Pécsi Tudományegyetem Klinikai Központ
🇭🇺Pécs, Hungary
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
🇮🇹Pavia, Italy
Hopital Raymond Poincare
🇫🇷Garches, France
Hopitaux Universitaires de Strasbourg - Hopital Hautepierre
🇫🇷Strasbourg, France
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania
🇧🇬Plovdiv, Bulgaria
General Childrens Hospital of Athens P & A Kyriakou
🇬🇷Athens, Greece
University of Santo Tomas Hospital
🇵🇭Manila, Philippines
Philippine Children's Medical Center
🇵🇭Quezon City, Philippines
Azienda Ospedaliero-Universitaria Meyer
🇮🇹Firenze, Italy
Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak
🇭🇺Budapest, Hungary
CHU Bordeaux - Hopital des Enfants
🇫🇷Bordeaux, France
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Heim Pal Gyermekkorhaz, Neurologiai Osztaly
🇭🇺Budapest, Hungary
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia
🇮🇹Pavia, Italy
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Capitol Medical Center Inc.
🇵🇭Quezon City, National Capital Region, Philippines
Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology
🇰🇷Seoul, Korea, Republic of
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Katedra i Klinika Neurologii Wieku Rozwojowego
🇵🇱Poznan, Poland
Spitalul Clinic de Urgente pentru Copii "Sf. Maria",
🇷🇴Iasi, Romania
Mother and Child Healthcare Institute Dr Vukan Cupic
🇷🇸Belgrade, Serbia
Ege University Medical Faculty Department of Pediatrics Health and Diseases
🇹🇷Izmir, Bornova, Turkey
Behcet Uz Children Disease and surgery Training and research hospital
🇹🇷Izmir, Konak, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Pendik, Turkey
Izmir Tepecik Training and Research Hospital
🇹🇷Izmir, Konak, Turkey
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
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
Center for Clinical and Translational Science
🇺🇸Lexington, Kentucky, United States
Kentucky Neuroscience Institute
🇺🇸Lexington, Kentucky, United States
Duke Children's Hospital and Health Center
🇺🇸Durham, North Carolina, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Duke Clinical Research Unit
🇺🇸Durham, North Carolina, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Pediatric Neurology, P.A.
🇺🇸Orlando, Florida, United States
University of Louisville Physicians
🇺🇸Louisville, Kentucky, United States
University of Kentucky Hospital Epilepsy Monitoring Unit
🇺🇸Lexington, Kentucky, United States
Kosair Charities Pediatric Clinical
🇺🇸Louisville, Kentucky, United States