Clinical trial NCT02072824: A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Official title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Onset Seizures
Keywords: Partial Onset Seizures
Epilepsy
Safety
Efficacy
Tolerability
Pregabalin
Lyrica
Adjunctive treatment
Placebo controlled
blinded
Eligibility Criteria
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 175
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Subject must have 3 partial onset seizures in the month prior to screening.
* 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:

* Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
* 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.

Primary outcomes:
measure: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
timeFrame: Day 1 up to Day 14
Secondary outcomes:
measure: Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
timeFrame: Day 1 up to Day 14
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to End of study (EOS) (maximum Day 25)
measure: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to EOS (maximum Day 25)
measure: Number of Adverse Events by Severity
timeFrame: Day 1 up to EOS (maximum Day 25)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From Baseline up to EOS (maximum Day 25)
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: From Baseline (BL) up to EOS (maximum Day 25)
measure: Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
timeFrame: Screening and EOS (maximum Day 25)
measure: Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
timeFrame: Baseline (BL) and EOS (maximum Day 25)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From screening up to EOS (maximum Day 25)
Locations:
city: Orlando
country: United States
facility: Pediatric Epilepsy Center of Central Florida
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, PA
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists, PA
state: Florida
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Minsk
country: Belarus
facility: GU Republican Scientific and Practical Center Mother and Child
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles Capitale
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski Ltd.
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" Ltd.
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Beijing
country: China
facility: Beijing Children's Hospital
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thueringen
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ippokratio
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Szent János Kórház es Észak Budai Egyesitett Kórházak
city: Budapest
country: Hungary
facility: Szent Margit Kórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Holon
country: Israel
facility: Pharmacy of The E. Wolfson Medical Center
city: Holon
country: Israel
facility: The E. Wolfson Medical Center
city: Tel Aviv
country: Israel
facility: Pharmacy of Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Saint George Hospital - University Medical Center
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
state: Cebu
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital
state: Cebu
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
city: Bucuresti
country: Romania
facility: Centrul Medical Unirea
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhmedklinika
state: Nizhegorodskaya Oblast
city: Perm
country: Russian Federation
facility: Perm State Medical University n. a. acad. E.A. Vagner
state: Permskiy KRAY
city: Moscow
country: Russian Federation
facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
city: Moscow
country: Russian Federation
facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
city: Perm
country: Russian Federation
facility: Perm State Medical University n. a. acad. E.A. Vagner
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Pediatric Medical University
city: Saint Petersburg
country: Russian Federation
facility: "Baltiyskaya Medicyna" LLC
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Smolensk
country: Russian Federation
facility: RSBHI Smolensk Regional Clinical Hospital
city: Ulyanovsk
country: Russian Federation
facility: SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
city: Ulyanovsk
country: Russian Federation
facility: SHI Central Clinical Medical Unit
city: Ulyanovsk
country: Russian Federation
facility: SHI Central Clinical Medical Unit
city: Yekaterinburg
country: Russian Federation
facility: MAI Children's City Clinical Hospital 9
city: Novi Sad
country: Serbia
facility: Institute for Child and Youth Healthcare of Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Mother and Child Healthcare Institute Dr Vukan Cupic
city: Belgrade
country: Serbia
facility: University Children's Hospital Belgrade
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital- Kaohsiung branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital, Faculty of Medicine, Mahidol University
state: Bangkok
city: Ratchathevee
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
state: Konak
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universitesi Tip Fakultesi
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia
city: Kyiv
country: Ukraine
facility: DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
city: Uzhgorod
country: Ukraine
facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.