Clinical trial NCT01747915: A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Tonic Clonic Seizures
Keywords: Primary Generalized Tonic Clonic Seizures
Epilepsy
Safety
Efficacy
Tolerability
Pregabalin
Lyrica
Adjunctive treatment
Placebo Controlled
Blinded
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 219
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Seizures classified as Primary Generalized Tonic Clonic Seizures
* Must have at least 1 PGTC seizure in the 8 weeks prior to screening
* Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
* Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
* Signed informed consent and assent if a minor
* Ability to comply with daily seizure and dosing diary requirements and all study procedures

Exclusion Criteria:

* A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
* Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
* Status Epilepticus within 1 year prior to screening
* Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
* Seizures related to drugs, alcohol, or acute medical illness
* Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
* Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
* Progressive inborn errors of metabolism.

Primary outcomes:
measure: Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
timeFrame: Day 1 up to Week 12
Secondary outcomes:
measure: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
timeFrame: Day 1 up to Week 12
Other outcomes:
Locations:
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
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: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Chinmay K. Patel, D.O.
state: Illinois
city: Hoffman Estates
country: United States
facility: St. Alexius Medical Center
state: Illinois
city: Canton
country: United States
facility: Ohio Clinical Research Partners, LLC
state: Ohio
city: San Antonio
country: United States
facility: Road Runner Research, Ltd
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital and Clinic
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Linz
country: Austria
facility: AKH Linz
city: Vitebsk
country: Belarus
facility: UZ Vitebsk Regional Childrens Clinical Centre
city: Vitebsk
country: Belarus
facility: UZ Vitebsk Regional Childrens Clinical Centre
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo
state: Canton Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
state: Canton Tuzla
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
state: Herzegovinaneretva Canton
city: Prijedor
country: Bosnia and Herzegovina
facility: Public Health Institution Hospital Dr Mladen Stojanovic
state: Republika Srpska
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Puls AD
city: Pleven
country: Bulgaria
facility: DCC Sv. Pantaleimon OOD
city: Pleven
country: Bulgaria
facility: Military Medical Academy - Multiprofile Hospital for Active Treatment
city: Plovdiv
country: Bulgaria
facility: MHAT Central Onco Hospital OOD
city: Ruse
country: Bulgaria
facility: Medical Center Teodora
city: Sofia
country: Bulgaria
facility: MHATNP Sveti Naum EAD
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska
city: Sofia
country: Bulgaria
facility: DCC Sveta Anna - Sofia
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Shanghai Huashan Hospital, Neurology Department
state: Shanghai
city: Split
country: Croatia
facility: University Hospital Center Split, Clinic for Neurology
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Amiens Cedex 1
country: France
facility: CHU d'Amiens - Picardie
city: Rennes
country: France
facility: CHRU de Rennes - Hôpital Pontchaillou
city: Rennes
country: France
facility: CHU d'Amiens Hopital Pontchaillou
city: Athens
country: Greece
facility: Eginition Hospital
city: Athens
country: Greece
facility: Athens Medical Center
city: Athens
country: Greece
facility: General Children's Hospital Penteli
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki "AHEPA"
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
city: Hodmezovasarhely
country: Hungary
facility: Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flór Ferenc Kórhaz
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: Bangalore
country: India
facility: St. John's Medical College Hospital
state: Karnataka
city: Mangalore
country: India
facility: Mangala Hospital & Mangala Kidney Foundation
state: Karnataka
city: Mumbai
country: India
facility: P D Hinduja National Hospital and Medical Research Centre
state: Maharashtra
city: Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University medical center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Beirut
country: Lebanon
facility: Saint George Hospital - University Medical Center
city: El Chouf
country: Lebanon
facility: Ain Wazein Medical Village
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Bijelo Polje
country: Montenegro
facility: Pzu Neuron
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
state: Cebu
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital
state: Cebu
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital, Rm Ph 7
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 Cathedral Heights Building
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Spzoo
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
city: Katowice
country: Poland
facility: NZOZ Novo Med
city: Katowice
country: Poland
facility: Neuro-Care Gabriela Klodowska
city: Krakow
country: Poland
facility: NZOZ "HIPOKRATES II" Sp. z o.o.
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Swidnik
country: Poland
facility: NZOZ IGNIS dr n. med. Alicja Lobinska
city: Warsaw
country: Poland
facility: Lecznica Medyczna ''Zycie"
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed
city: Bucuresti
country: Romania
facility: CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
city: Bucuresti
country: Romania
facility: Sapiens Medical Center
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
city: Sibiu
country: Romania
facility: Spitalul de Psihiatrie "Dr. Gh. Preda"
city: Pgt. Roshchino
country: Russian Federation
facility: SPHI Leningrad Regional Psychoneurological Dispensary
state: Leningrad Region
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: Kazan
country: Russian Federation
facility: GBOU VPO "Kazan State Medical University" of Roszdrav
state: Republic OF Tatarstan
city: Kazan
country: Russian Federation
facility: Republican clinical hospital
state: Republic OF Tatarstan
city: Pyatigorsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Stavropol region
state: Stavropol Region
city: Barnaul
country: Russian Federation
facility: TSBHI City Hospital No. 5 of Barnaul
city: Chelyabinsk
country: Russian Federation
facility: MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution
city: Novosibirsk
country: Russian Federation
facility: LLC City Neurological Center "Sibneiromed"
city: Perm
country: Russian Federation
facility: Perm State Medical University n. a. acad. E.A. Vagner
city: Saint Petersburg
country: Russian Federation
facility: FSBI V.M. Bekhterev National Research Medical Center for
city: Saint Petersburg
country: Russian Federation
facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5
city: Saint Petersburg
country: Russian Federation
facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5
city: Saint-Petersburg
country: Russian Federation
facility: SPHI Leningrad Regional Psychoneurological Dispensary
city: Smolensk
country: Russian Federation
facility: Regional State Budgetary Institution of Ministry of Health
city: Smolensk
country: Russian Federation
facility: RSBHI Smolensk Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: GBOU VPO Smolensk State Medical University
city: Ulyanovsk
country: Russian Federation
facility: SHI "Central Clinical Medical Unit
city: Ulyanovsk
country: Russian Federation
facility: SHI "Central Clinical Medical Unit
city: Novi Sad
country: Serbia
facility: Institute for Child and Youth Healthcare of Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Institute for Mental Health
city: Belgrade
country: Serbia
facility: University Children's Hospital
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Hlohovec
country: Slovakia
facility: Nemocnica s poliklinikou Hlohovec, s.r.o.
city: Hlohovec
country: Slovakia
facility: Neurologicka ambulancia MUDr. Eva Gasparova
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: UST Kaynarca/pendik
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty Department Of Neurology
city: Izmir
country: Turkey
facility: Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
city: Manisa
country: Turkey
facility: Celal Bayar University School of Medicine, Neurology Department
city: S. Oleksandrivka
country: Ukraine
facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
state: Komintern. R-N, Odeska OBL.
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 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: Kharkiv
country: Ukraine
facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
city: Kyiv
country: Ukraine
facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
city: Lviv
country: Ukraine
facility: Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
city: Odesa
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
city: Uzhgorod
country: Ukraine
facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
city: Zaporizhzhia
country: Ukraine
facility: Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
city: Birmingham
country: United Kingdom
facility: The Barberry National Centre for Mental Health
state: WEST Midlands
city: London
country: United Kingdom
facility: Barts Health NHS Foundation Trust, The Royal London Hospital
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: ABMU Local Health Board, Morriston Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Driscoll J, Almas M, Gregorian G, Kyrychenko A, Makedonska I, Liu J, Patrick J, Scavone JM, Antinew J; 1105 Study Group. Pregabalin as adjunctive therapy in adult and pediatric patients with generalized tonic-clonic seizures: A randomized, placebo-controlled trial. Epilepsia Open. 2021 Jun;6(2):381-393. doi: 10.1002/epi4.12492. Epub 2021 May 16.