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

Primary Purpose

Epilepsy, Partial Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin add-on therapy
Pregabalin add-on therapy
Pregabalin add-on therapy
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Partial Seizures focused on measuring safety, efficacy, partial onset seizures, pediatric, pregabalin, placebo-controlled, double-blind

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Center for Neurosciences
  • Arkansas Children's Hospital
  • Children's Hospital Los Angeles
  • Children´s Hospital Los Angeles
  • Axcess Medical Research
  • Laszlo J. Mate, M.D., P.A.
  • Pediatric Neurology, P.A.
  • Tallahassee Neurological Clinic
  • Center for Clinical and Translational Science
  • Kentucky Neuroscience Institute
  • University of Kentucky Hospital Epilepsy Monitoring Unit
  • University of Kentucky Hospital Pharmacy, UK Chandler Hosptial
  • Kosair Charities Pediatric Clinical
  • Kosair Children's Hospital
  • University of Louisville Physicians
  • Saint Peter's University Hospital
  • Duke Children's Hospital and Health Center
  • Duke Clinical Research Unit
  • Akron Children's Hospital
  • Road Runner Research, Ltd.
  • Centre Hospitalier Neurologique William Lennox
  • HUDERF
  • Cliniques Universitaires de Bruxelles Hôpital Erasme
  • UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania
  • Fakultni nemocnice Brno - Detska nemocnice
  • Fakultni nemocnice v Motole
  • CHU Bordeaux - Hopital des Enfants
  • Hôpital Mère Enfant
  • Hopital Raymond Poincare
  • Hopitaux Universitaires de Strasbourg - Hopital Hautepierre
  • General Childrens Hospital of Athens P & A Kyriakou
  • General Children's Hospital Penteli
  • Dr. Kenessey Albert Korhaz es Rendelointezet
  • Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak
  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
  • Heim Pal Gyermekkorhaz, Neurologiai Osztaly
  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
  • Pécsi Tudományegyetem Klinikai Központ
  • Bnai Zion Medical Center
  • A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
  • Azienda Ospedaliero-Universitaria Meyer
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
  • Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Paediatric Department
  • Hospital Kuala Lumpur
  • Cebu Doctors' University Hospital
  • Center for Neurodiagnostic and Therapeutic Services
  • Capitol Medical Center Inc.
  • Cebu Doctors' University Hospital
  • University of Santo Tomas Hospital
  • St. Luke's Medical Center
  • Philippine Children's Medical Center
  • Klinika Neurologii Rozwojowej
  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
  • Katedra i Klinika Neurologii Wieku Rozwojowego
  • Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka
  • Spitalul clinic de copii Dr. Victor Gomoiu
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
  • Spitalul Clinic de Urgente pentru Copii "Sf. Maria",
  • Spitalul de Psihiatrie Dr. Ghe. Preda
  • Centrul Medical Dr. Bacos Cosma
  • Institute for Child and Youth Healthcare of Vojvodina
  • Mother and Child Healthcare Institute Dr Vukan Cupic
  • University Children's Hospital Belgrade
  • Clinical Center of Kragujevac
  • National University Hospital
  • KK Women's and Children's Hospital
  • Ege University Medical Faculty Department of Pediatrics Health and Diseases
  • Karadeniz Technical University Faculty of Medicine Farabi Hospital
  • Izmir Tepecik Training and Research Hospital
  • Behcet Uz Children Disease and surgery Training and research hospital
  • Marmara University Pendik Training and Research Hospital
  • Hacettepe University Medical Faculty
  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia
  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
  • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
  • Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,
  • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
  • Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",
  • Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi
  • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Pregabalin Level 1 (max 150 mg/day)

Pregabalin Level 2 (max 600 mg day)

Arm Description

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 6, 2011
Last Updated
January 15, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01389596
Brief Title
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Acronym
PERIWINKLE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2011 (Actual)
Primary Completion Date
August 10, 2016 (Actual)
Study Completion Date
August 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 of age with partial onset seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures
Keywords
safety, efficacy, partial onset seizures, pediatric, pregabalin, placebo-controlled, double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Pregabalin Level 1 (max 150 mg/day)
Arm Type
Experimental
Arm Title
Pregabalin Level 2 (max 600 mg day)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pregabalin add-on therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin add-on therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin add-on therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase
Description
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).
Time Frame
Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
Title
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase
Description
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).
Time Frame
Day 1 up to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase
Description
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.
Time Frame
Day 1 up to Week 12
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.
Time Frame
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Title
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
Time Frame
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Title
Number of Adverse Events by Severity
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Time Frame
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Title
Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline
Description
The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.
Time Frame
Baseline (4 week prior to Day 1 of treatment)
Title
Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period
Description
C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported
Time Frame
Day 1 up to Week 13
Title
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age
Description
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.
Time Frame
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Title
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age
Description
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Time Frame
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Title
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age
Description
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Time Frame
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task
Description
CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Time Frame
Baseline (pre-dose at Day 1), Week 12
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks
Description
CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press "Yes" response key, otherwise "no". There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Time Frame
Baseline (pre-dose at Day 1), Week 12
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Description
Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).
Time Frame
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Title
Number of Participants With Vital Signs Abnormalities
Description
Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.
Time Frame
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Title
Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations
Description
Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.
Time Frame
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.
Time Frame
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Title
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13
Description
Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator.
Time Frame
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children´s Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Laszlo J. Mate, M.D., P.A.
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Pediatric Neurology, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Center for Clinical and Translational Science
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kentucky Neuroscience Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Kentucky Hospital Epilepsy Monitoring Unit
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Kentucky Hospital Pharmacy, UK Chandler Hosptial
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kosair Charities Pediatric Clinical
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Physicians
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Duke Children's Hospital and Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke Clinical Research Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Centre Hospitalier Neurologique William Lennox
City
Ottignies
State/Province
Brabant Wallon
ZIP/Postal Code
1340
Country
Belgium
Facility Name
HUDERF
City
Brussels
State/Province
Brussels-capital
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires de Bruxelles Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno - Detska nemocnice
City
Brno - Cerna Pole
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
CHU Bordeaux - Hopital des Enfants
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg - Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
General Childrens Hospital of Athens P & A Kyriakou
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Children's Hospital Penteli
City
Athens
ZIP/Postal Code
15236
Country
Greece
Facility Name
Dr. Kenessey Albert Korhaz es Rendelointezet
City
Balassagyarmat
ZIP/Postal Code
H-2660
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
H-1023
Country
Hungary
Facility Name
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Heim Pal Gyermekkorhaz, Neurologiai Osztaly
City
Budapest
ZIP/Postal Code
H-1089
Country
Hungary
Facility Name
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
City
Budapest
ZIP/Postal Code
H-1146
Country
Hungary
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3104802
Country
Israel
Facility Name
A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120 752
Country
Korea, Republic of
Facility Name
Paediatric Department
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Cebu Doctors' University Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Center for Neurodiagnostic and Therapeutic Services
City
Sta. Cruz
State/Province
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Capitol Medical Center Inc.
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Cebu Doctors' University Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
University of Santo Tomas Hospital
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Philippine Children's Medical Center
City
Quezon City
ZIP/Postal Code
1105
Country
Philippines
Facility Name
Klinika Neurologii Rozwojowej
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
City
Kielce
ZIP/Postal Code
25316
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Facility Name
Katedra i Klinika Neurologii Wieku Rozwojowego
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka
City
Wroclaw
ZIP/Postal Code
54-049
Country
Poland
Facility Name
Spitalul clinic de copii Dr. Victor Gomoiu
City
Bucuresti
ZIP/Postal Code
022102
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic de Urgente pentru Copii "Sf. Maria",
City
Iasi
ZIP/Postal Code
700309
Country
Romania
Facility Name
Spitalul de Psihiatrie Dr. Ghe. Preda
City
Sibiu
ZIP/Postal Code
550 082
Country
Romania
Facility Name
Centrul Medical Dr. Bacos Cosma
City
Timisoara
ZIP/Postal Code
300314
Country
Romania
Facility Name
Institute for Child and Youth Healthcare of Vojvodina
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Mother and Child Healthcare Institute Dr Vukan Cupic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Children's Hospital Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Ege University Medical Faculty Department of Pediatrics Health and Diseases
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine Farabi Hospital
City
Trabzon
State/Province
Farabi
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35120
Country
Turkey
Facility Name
Behcet Uz Children Disease and surgery Training and research hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35210
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
State/Province
Sihhiye/ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi
City
Odesa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",
City
S. Oleksandrivka
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
30688135
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081041&StudyName=A%20Study%20of%20the%20Efficacy%20and%20Safety%20of%20Pregabalin%20as%20Add-On%20Therapy%20for%20Partial%20Onset%20Seizures%20in%20Children%20Ages%204-16%20Years
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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