A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
NCT ID: NCT02072824
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
175 participants
INTERVENTIONAL
2014-09-16
2018-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study Drug Level 1
Pregabalin Dose Level 1
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Study Drug Level 2
Pregabalin Dose Level 2
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Placebo
Placebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Interventions
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Pregabalin Dose Level 1
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Pregabalin Dose Level 2
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Placebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Eligibility Criteria
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Inclusion Criteria
* Subject must have 2 partial onset seizures during the 48 hour baseline phase.
* Signed Informed Consent.
* On 1-3 stable anti-epileptic drugs at screening.
Exclusion Criteria
* Lennox-Gasteau, BECTS, and Dravet's syndrome.
* Status epliepticus within 1 year of screening.
* Any change in AED regimen with 7 days of screening.
* Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
* Progressive errors of metabolism.
1 Month
3 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pediatric Epilepsy Center of Central Florida
Orlando, Florida, United States
Pediatric Neurology, PA
Orlando, Florida, United States
Pediatric Epilepsy & Neurology Specialists, PA
Tampa, Florida, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
GU Republican Scientific and Practical Center Mother and Child
Minsk, , Belarus
UZ Brussel
Brussels, Brussels Capital, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
UMHAT Dr. Georgi Stranski Ltd.
Pleven, , Bulgaria
UMHAT "Sveti Georgi" Ltd.
Plovdiv, , Bulgaria
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Beijing Children's Hospital
Beijing, , China
Hopital Raymond Poincare
Garches, , France
Universitaetsklinikum Jena
Jena, Thuringia, Germany
University General Hospital Attikon
Athens, , Greece
General Hospital of Thessaloniki Ippokratio
Thessaloniki, , Greece
Dr. Kenessey Albert Korhaz es Rendelointezet
Balassagyarmat, , Hungary
Szent János Kórház es Észak Budai Egyesitett Kórházak
Budapest, , Hungary
Szent Margit Kórház
Budapest, , Hungary
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
Budapest, , Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, , Hungary
Pharmacy of The E. Wolfson Medical Center
Holon, , Israel
The E. Wolfson Medical Center
Holon, , Israel
Pharmacy of Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
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
Cebu Doctors' University Hospital
Cebu City, CEBU, Philippines
Perpetual Succour Hospital
Cebu City, CEBU, Philippines
Manila Doctors Hospital
Manila, , Philippines
Metropolitan Medical Center
Manila, , Philippines
University of Santo Tomas Hospital
Manila, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Philippine Children's Medical Center
Quezon City, , Philippines
Centrul Medical Unirea
Bucharest, , Romania
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iași, , Romania
Nizhmedklinika
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Permskiy KRAY, 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
Perm State Medical University n. a. acad. E.A. Vagner
Perm, , Russia
LLC Medical Technologies
Saint Petersburg, , Russia
LLC Medical Technologies
Saint Petersburg, , Russia
St. Petersburg State Pediatric Medical University
Saint Petersburg, , Russia
"Baltiyskaya Medicyna" LLC
Saint Petersburg, , Russia
RSBHI Smolensk Regional Clinical Hospital
Smolensk, , Russia
SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
Ulyanovsk, , Russia
SHI Central Clinical Medical Unit
Ulyanovsk, , Russia
SHI Central Clinical Medical Unit
Ulyanovsk, , Russia
MAI Children's City Clinical Hospital 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
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Chang Gung Memorial Hospital- Kaohsiung branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Siriraj Hospital, Faculty of Medicine, Mahidol University
Bangkoknoi, Bangkok, Thailand
Phramongkutklao Hospital
Ratchathevee, Bangkok, Thailand
Izmir Tepecik Training and Research Hospital
Izmir, Konak, Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon, , Turkey (Türkiye)
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
Dnipro, , Ukraine
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipro, , Ukraine
Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, , Ukraine
DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
Kyiv, , Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
Uzhhorod, , Ukraine
Countries
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References
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Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-003420-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0081042
Identifier Type: -
Identifier Source: org_study_id
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