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Generalized Tonic Clonic SeizuresPhase 3NCT01747915

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.

A Phase 3 study testing Pregabalin Dose Level 1 and Pregabalin Dose Level 2 in people with Generalized Tonic Clonic Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 127 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 5 to 65 years
Conditions the study is for
Generalized Tonic Clonic Seizures
What is being tested?
Pregabalin Dose Level 1 and Pregabalin Dose Level 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
219 participants
Where
127 sitesin 26 countries
Study dates
3 Apr 2013to 20 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

127 sites in 26 countries.

127 sites in 26 countries

Russia20 sites

  • TSBHI City Hospital No. 5 of Barnaul

    Barnaul, 656045

  • MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1

    Chelyabinsk, 454048

  • GBOU VPO "Kazan State Medical University" of Roszdrav

    Kazan', Tatarstan Republic, 420012

  • Republican clinical hospital

    Kazan', Tatarstan Republic, 420064

  • Non-state Healthcare Institution

    Moscow, 129128

  • Nizhmedklinika

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603159

  • LLC City Neurological Center "Sibneiromed"

    Novosibirsk, 630091

  • Perm State Medical University n. a. acad. E.A. Vagner

    Perm, Permskiy KRAY, 614000

  • Perm State Medical University n. a. acad. E.A. Vagner

    Perm, 614990

  • SPHI Leningrad Regional Psychoneurological Dispensary

    Pgt. Roshchino, Leningradskaya Oblast', 188820

  • State Budgetary Healthcare Institution of Stavropol region

    Pyatigorsk, Stavropol Kray, 357538

  • SPHI Leningrad Regional Psychoneurological Dispensary

    Saint Petersburg, 191040

  • FSBI V.M. Bekhterev National Research Medical Center for

    Saint Petersburg, 192019

  • SBHI of Saint Petersburg Psychoneurological Dispensary #5

    Saint Petersburg, 195112

  • SBHI of Saint Petersburg Psychoneurological Dispensary #5

    Saint Petersburg, 195176

  • Regional State Budgetary Institution of Ministry of Health

    Smolensk, 214018

  • RSBHI Smolensk Regional Clinical Hospital

    Smolensk, 214018

  • GBOU VPO Smolensk State Medical University

    Smolensk, 214019

  • SHI "Central Clinical Medical Unit

    Ulyanovsk, 432026

  • SHI "Central Clinical Medical Unit

    Ulyanovsk, 432045

Other trials in Russia

United States12 sites

  • Ohio Clinical Research Partners, LLC

    Canton, Ohio, 44718

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • Chinmay K. Patel, D.O.

    Hoffman Estates, Illinois, 60169

  • St. Alexius Medical Center

    Hoffman Estates, Illinois, 60169

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Axcess Medical Research

    Loxahatchee Groves, Florida, 33470

  • Pediatric Epilepsy Center of Central Florida

    Orlando, Florida, 32819

  • Pediatric Neurology, PA

    Orlando, Florida, 32819

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057

  • Road Runner Research, Ltd

    San Antonio, Texas, 78249

  • Scott & White Memorial Hospital and Clinic

    Temple, Texas, 76508

Other trials in United States

Ukraine11 sites

  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"

    Dnipro, 49027

  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

    Dnipro, 49100

  • Ivano-Frankivska oblasna dytiacha klinichna likarnia

    Ivano-Frankivsk, 76018

  • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

    Kharkiv, 61068

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li

    Kharkiv, 61068

  • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

    Kyiv, 04209

  • Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"

    Lviv, 79010

  • Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi

    Odesa, 65006

  • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"

    S. Oleksandrivka, Komintern. R-N, Odeska OBL., 67513

  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,

    Uzhhorod, 88018

  • Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia

    Zaporizhzhya, 69068

Other trials in Ukraine

Poland9 sites

  • COPERNICUS Podmiot Leczniczy Spzoo

    Gdansk, 80-803

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

    Katowice, 40-123

  • NZOZ Novo Med

    Katowice, 40-650

  • Neuro-Care Gabriela Klodowska

    Katowice, 40-749

  • NZOZ "HIPOKRATES II" Sp. z o.o.

    Krakow, 31-223

  • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

    Lublin, 20-090

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • NZOZ IGNIS dr n. med. Alicja Lobinska

    Świdnik, 21-040

  • Lecznica Medyczna ''Zycie"

    Warsaw, 00-453

Other trials in Poland

Bulgaria8 sites

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad, 2700

  • DCC Sv. Pantaleimon OOD

    Pleven, 5800

  • Military Medical Academy - Multiprofile Hospital for Active Treatment

    Pleven, 5800

  • MHAT Central Onco Hospital OOD

    Plovdiv, 4000

  • Medical Center Teodora

    Rousse, 7000

  • MHATNP Sveti Naum EAD

    Sofia, 1113

  • UMHAT Aleksandrovska

    Sofia, 1431

  • DCC Sveta Anna - Sofia

    Sofia, 1784

Other trials in Bulgaria

India7 sites

  • St. John's Medical College Hospital

    Bangalore, Karnataka, 560034

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, Karnataka, 575003

  • P D Hinduja National Hospital and Medical Research Centre

    Mumbai, Maharashtra, 400016

  • Getwell Hospital and Research Institute

    Nagpur, Maharashtra, 440012

  • Indraprastha Apollo Hospitals

    New Delhi, National Capital Territory of Delhi, 110076

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • KEM Hospital Research Centre

    Pune, Maharashtra, 411011

Other trials in India

Philippines7 sites

  • Cebu Doctors' University Hospital

    Cebu City, CEBU, 6000

  • Perpetual Succour Hospital

    Cebu City, CEBU, 6000

  • Cebu Doctors' University Hospital, Rm Ph 7

    Cebu City, 6000

  • Manila Doctors Hospital

    Manila, 1000

  • Metropolitan Medical Center

    Manila, 1003

  • University of Santo Tomas Hospital

    Manila, 1008

  • St. Luke's Medical Center Cathedral Heights Building

    Quezon City

Other trials in Philippines

Romania6 sites

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed

    Brasov, 500283

  • CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria

    Bucharest, 010042

  • Sapiens Medical Center

    Bucharest, 030583

  • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"

    Iași, 700309

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

    Iași, 700309

  • Spitalul de Psihiatrie "Dr. Gh. Preda"

    Sibiu, 550082

Other trials in Romania

Bosnia and Herzegovina4 sites

  • University Clinical Hospital Mostar

    Mostar, Herzegovinaneretva Canton, 88000

  • Public Health Institution Hospital Dr Mladen Stojanovic

    Prijedor, Republika Srpska, 79101

  • University Clinical Center Sarajevo

    Sarajevo, Canton Sarajevo, 71000

  • University Clinical Center Tuzla

    Tuzla, Canton Tuzla, 75000

Other trials in Bosnia and Herzegovina

Greece4 sites

  • Eginition Hospital

    Athens, 11528

  • Athens Medical Center

    Athens, 15125

  • General Children's Hospital Penteli

    Athens, 15236

  • University General Hospital of Thessaloniki "AHEPA"

    Thessaloniki, 54636

Other trials in Greece

Serbia4 sites

  • Institute for Mental Health

    Belgrade, 11000

  • University Children's Hospital

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Institute for Child and Youth Healthcare of Vojvodina

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Korea4 sites

  • Keimyung University Dongsan Hospital

    Daegu, Korea, 41931

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University medical center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Eskisehir Osmangazi University Medical Faculty Department Of Neurology

    Eskişehir, 26480

  • Marmara University Pendik Training and Research Hospital

    Istanbul, UST Kaynarca/pendik, 34899

  • Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları

    Izmir, 35340

  • Celal Bayar University School of Medicine, Neurology Department

    Manisa, 45010

Other trials in Turkey (Türkiye)

United Kingdom4 sites

  • The Barberry National Centre for Mental Health

    Birmingham, WEST Midlands, B15 2FG

  • Barts Health NHS Foundation Trust, The Royal London Hospital

    London, E1 2AT

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD

  • ABMU Local Health Board, Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

China3 sites

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Shanghai Huashan Hospital, Neurology Department

    Shanghai, Shanghai Municipality, 201100

Other trials in China

France3 sites

  • CHU d'Amiens - Picardie

    Amiens, 80054

  • CHRU de Rennes - Hôpital Pontchaillou

    Rennes, 35033

  • CHU d'Amiens Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Hungary3 sites

  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

    Budapest, H-1083

  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako

    Hódmezővásárhely, H-6800

  • Pest Megyei Flór Ferenc Kórhaz

    Kistarcsa, 2143

Other trials in Hungary

Austria2 sites

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • AKH Linz

    Linz, 4021

Other trials in Austria

Belarus2 sites

  • UZ Vitebsk Regional Childrens Clinical Centre

    Vitebsk, 210015

  • UZ Vitebsk Regional Childrens Clinical Centre

    Vitebsk, 210022

Other trials in Belarus

Denmark2 sites

  • Aarhus University Hospital

    Aarhus C, 8000

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

Lebanon2 sites

  • Saint George Hospital - University Medical Center

    Beirut, NAP

  • Ain Wazein Medical Village

    El Chouf

Other trials in Lebanon

Slovakia2 sites

  • Nemocnica s poliklinikou Hlohovec, s.r.o.

    Hlohovec, 92001

  • Neurologicka ambulancia MUDr. Eva Gasparova

    Hlohovec, 92001

Other trials in Slovakia

Croatia1 site

  • University Hospital Center Split, Clinic for Neurology

    Split, 21000

Other trials in Croatia

Malaysia1 site

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30990

Other trials in Malaysia

Montenegro1 site

  • Pzu Neuron

    Bijelo Polje, 84000

Other trials in Montenegro

Spain1 site

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Being tested
Pregabalin Dose Level 1, Pregabalin Dose Level 2, Placebo
Keywords
Primary Generalized Tonic Clonic Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo Controlled, Blinded
Medical subject headings
Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregabalin Dose Level 1Drug

    Also called Lyrica Dose Level 1

    Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

  • Pregabalin Dose Level 2Drug

    Also called Lyrica Dose Level 2

    Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

  • PlaceboDrug

    Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.

Study groups in NCT01747915
Study groupRoleWhat they receive
Study Drug Level 1ExperimentalNot described
Receives: Drug: Pregabalin Dose Level 1
Study Drug Level 2ExperimentalNot described
Receives: Drug: Pregabalin Dose Level 2
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase

    All PGTC 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 PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind 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).

    Measured: Day 1 up to Week 12

Secondary outcomes (1)

  1. 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

    Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.

    Measured: Day 1 up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2012 (estimated)
  2. Study start3 Apr 2013
  3. Primary completion20 Feb 2019
  4. Study completion20 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01747915
Sponsor's protocol ID
A0081105
Other IDs
2010-023263-18
Status last verified
Aug 2019
First submitted
27 Nov 2012
Last updated
20 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • 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.

    PubMed 34033265

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin Dose Level 1 and Pregabalin Dose Level 2 in people with Generalized Tonic Clonic Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 127 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Russia, United States, Ukraine, Poland, Bulgaria and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase (time frame: Day 1 up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01747915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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