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Epilepsy, Partial SeizuresPhase 3PERIWINKLENCT01389596

A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

A Phase 3 study testing Pregabalin add-on therapy in people with Epilepsy, Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 86 sites in 18 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

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… Read more about this study

Who is it for?
Ages 4 to 16 years
Conditions the study is for
Epilepsy, Partial Seizures
What is being tested?
Pregabalin add-on therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
295 participants
Where
86 sitesin 18 countries
Study dates
27 Sep 2011to 10 Aug 2016
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 4 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

86 sites in 18 countries.

86 sites in 18 countries

United States20 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Duke Children's Hospital and Health Center

    Durham, North Carolina, 27710

  • Duke Clinical Research Unit

    Durham, North Carolina, 27710

  • Center for Clinical and Translational Science

    Lexington, Kentucky, 40536

  • Kentucky Neuroscience Institute

    Lexington, Kentucky, 40536

  • University of Kentucky Hospital Epilepsy Monitoring Unit

    Lexington, Kentucky, 40536

  • University of Kentucky Hospital Pharmacy, UK Chandler Hosptial

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Children´s Hospital Los Angeles

    Los Angeles, California, 90027

  • Kosair Charities Pediatric Clinical

    Louisville, Kentucky, 40202

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202

  • University of Louisville Physicians

    Louisville, Kentucky, 40202

  • Axcess Medical Research

    Loxahatchee Groves, Florida, 33470

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Laszlo J. Mate, M.D., P.A.

    North Palm Beach, Florida, 33408

  • Pediatric Neurology, P.A.

    Orlando, Florida, 32819

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78258

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Center for Neurosciences

    Tucson, Arizona, 85718

Other trials in United States

Ukraine9 sites

  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia

    Dnipropetrovsk, 49027

  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

    Dnipropetrovsk, 49100

  • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

    Kharkiv, 61068

  • Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,

    Kharkiv, 61068

  • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

    Kyiv, 04209

  • Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",

    Odesa, 65006

  • Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi

    Odesa, 65031

  • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",

    S. Oleksandrivka, 67513

  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,

    Uzhhorod, 88018

Other trials in Ukraine

Philippines7 sites

  • Cebu Doctors' University Hospital

    Cebu City, CEBU, 6000

  • Cebu Doctors' University Hospital

    Cebu City, 6000

  • University of Santo Tomas Hospital

    Manila, 1008

  • Capitol Medical Center Inc.

    Quezon City, National Capital Region, 1100

  • St. Luke's Medical Center

    Quezon City, 1102

  • Philippine Children's Medical Center

    Quezon City, 1105

  • Center for Neurodiagnostic and Therapeutic Services

    Sta Cruz, Manila, 1003

Other trials in Philippines

Hungary6 sites

  • Dr. Kenessey Albert Korhaz es Rendelointezet

    Balassagyarmat, H-2660

  • Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak

    Budapest, H-1023

  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

    Budapest, H-1083

  • Heim Pal Gyermekkorhaz, Neurologiai Osztaly

    Budapest, H-1089

  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

    Budapest, H-1146

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, 7623

Other trials in Hungary

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty

    Ankara, Sihhiye/ankara, 06100

  • Marmara University Pendik Training and Research Hospital

    Istanbul, Pendik, 34890

  • Ege University Medical Faculty Department of Pediatrics Health and Diseases

    Izmir, Bornova, 35100

  • Izmir Tepecik Training and Research Hospital

    Izmir, Konak, 35120

  • Behcet Uz Children Disease and surgery Training and research hospital

    Izmir, Konak, 35210

  • Karadeniz Technical University Faculty of Medicine Farabi Hospital

    Trabzon, Farabi, 61080

Other trials in Turkey (Türkiye)

Poland5 sites

  • Klinika Neurologii Rozwojowej

    Gdansk, 80-952

  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

    Kielce, 25316

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

    Krakow, 31-503

  • Katedra i Klinika Neurologii Wieku Rozwojowego

    Poznan, 60-355

  • Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka

    Wroclaw, 54-049

Other trials in Poland

Romania5 sites

  • Spitalul clinic de copii Dr. Victor Gomoiu

    Bucharest, 022102

  • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

    Bucharest, 041914

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

    Iași, 700309

  • Spitalul de Psihiatrie Dr. Ghe. Preda

    Sibiu, 550 082

  • Centrul Medical Dr. Bacos Cosma

    Timișoara, 300314

Other trials in Romania

France4 sites

  • CHU Bordeaux - Hopital des Enfants

    Bordeaux, 33076

  • Hôpital Mère Enfant

    Bron, 69677

  • Hopital Raymond Poincare

    Garches, 92380

  • Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

    Strasbourg, 67098

Other trials in France

Italy4 sites

  • A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi

    Ancona, 60123

  • Azienda Ospedaliero-Universitaria Meyer

    Florence, 50139

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia

    Pavia, 27100

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

    Pavia, 27100

Other trials in Italy

Serbia4 sites

  • Mother and Child Healthcare Institute Dr Vukan Cupic

    Belgrade, 11000

  • University Children's Hospital Belgrade

    Belgrade, 11000

  • Clinical Center of Kragujevac

    Kragujevac, 34000

  • Institute for Child and Youth Healthcare of Vojvodina

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Belgium3 sites

  • HUDERF

    Brussels, Brussels Capital, 1020

  • Cliniques Universitaires de Bruxelles Hôpital Erasme

    Brussels, 1070

  • Centre Hospitalier Neurologique William Lennox

    Ottignies, Brabant Wallon, 1340

Other trials in Belgium

South Korea3 sites

  • Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology

    Seoul, 06351

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120 752

Other trials in South Korea

Czechia2 sites

  • Fakultni nemocnice Brno - Detska nemocnice

    Brno - Cerna Pole, 613 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Greece2 sites

  • General Childrens Hospital of Athens P & A Kyriakou

    Athens, 11527

  • General Children's Hospital Penteli

    Athens, 15236

Other trials in Greece

Malaysia2 sites

  • Paediatric Department

    Ipoh, Perak, 30990

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

Other trials in Malaysia

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

Bulgaria1 site

  • UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania

    Plovdiv, 4000

Other trials in Bulgaria

Israel1 site

  • Bnai Zion Medical Center

    Haifa, 3104802

Other trials in Israel

About this study

Official title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

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.

Being tested
Pregabalin add-on therapy
Keywords
safety, efficacy, partial onset seizures, pediatric, pregabalin, placebo-controlled, double-blind
Medical subject headings
Epilepsy, Seizures

What participants receive

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

  • Pregabalin add-on therapyDrug

    Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

  • Pregabalin add-on therapyDrug

    Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

  • Pregabalin add-on therapyDrug

    Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

Study groups in NCT01389596
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Pregabalin add-on therapy
Pregabalin Level 1 (max 150 mg/day)ExperimentalNot described
Receives: Drug: Pregabalin add-on therapy
Pregabalin Level 2 (max 600 mg day)ExperimentalNot described
Receives: Drug: Pregabalin add-on therapy

What is being measured

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

  1. Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase

    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).

    Measured: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])

  2. Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase

    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).

    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 Seizure Rate During the 12 Week Treatment Phase

    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.

    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 posted8 Jul 2011 (estimated)
  2. Study start27 Sep 2011
  3. Primary completion10 Aug 2016
  4. Study completion10 Aug 2016

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
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389596
Sponsor's protocol ID
A0081041
Other IDs
2010-020852-79, XALCORY 1014
Acronym
PERIWINKLE
Status last verified
Jan 2019
First submitted
6 Jul 2011
Last updated
20 Jan 2021
Data monitoring committee
Yes
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

  • Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27.

    PubMed 30688135

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin add-on therapy in people with Epilepsy, Partial Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 86 sites in 18 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 5 inclusion and 7 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 86 sites in United States, Ukraine, Philippines, Hungary, Turkey (Türkiye) and 13 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 21 Mar 2017). 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 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase (time frame: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])). The study lists 2 primary outcomes in all. 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 NCT01389596, 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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