A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

NCT02072824 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: A00810422013-003420-37
• Study Type: interventional
• Target: 175
• Locations: 22 countries
• Sites: 71

Brief Summary

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

Conditions

Partial Onset Seizures

Keywords

Partial Onset Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo controlled; blinded; Eligibility Criteria

Outcome Measures

Primary Outcomes (1)

• Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase

  All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).

  Day 1 up to Day 14

Secondary Outcomes (1)

• Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase

  Day 1 up to Day 14

Other Outcomes (8)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to End of study (EOS) (maximum Day 25)

• Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to EOS (maximum Day 25)

• Number of Adverse Events by Severity

  Day 1 up to EOS (maximum Day 25)

Study Arms (3)

Study Drug Level 1

EXPERIMENTAL

Drug: Pregabalin Dose Level 1

Study Drug Level 2

EXPERIMENTAL

Drug: Pregabalin Dose Level 2

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin Dose Level 1 DRUG

Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

Study Drug Level 1

Pregabalin Dose Level 2 DRUG

Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

Study Drug Level 2

Placebo DRUG

Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase

Placebo

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must have 3 partial onset seizures in the month prior to screening.
• Subject must have 2 partial onset seizures during the 48 hour baseline phase.
• Signed Informed Consent.
• On 1-3 stable anti-epileptic drugs at screening.

You may not qualify if:

• Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
• Lennox-Gasteau, BECTS, and Dravet's syndrome.
• Status epliepticus within 1 year of screening.
• Any change in AED regimen with 7 days of screening.
• Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
• Progressive errors of metabolism.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (72)

Pediatric Epilepsy Center of Central Florida

Orlando, Florida, 32819, United States

Location

Pediatric Neurology, PA

Orlando, Florida, 32819, United States

Location

Pediatric Epilepsy & Neurology Specialists, PA

Tampa, Florida, 33609, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Road Runner Research, Ltd.

San Antonio, Texas, 78249, United States

Location

GU Republican Scientific and Practical Center Mother and Child

Minsk, 220053, Belarus

Location

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

UMHAT Dr. Georgi Stranski Ltd.

Pleven, 5800, Bulgaria

Location

UMHAT "Sveti Georgi" Ltd.

Plovdiv, 4002, Bulgaria

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Beijing Children's Hospital

Beijing, 100045, China

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

Universitaetsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

University General Hospital Attikon

Athens, 12462, Greece

Location

General Hospital of Thessaloniki Ippokratio

Thessaloniki, 54642, Greece

Location

Dr. Kenessey Albert Korhaz es Rendelointezet

Balassagyarmat, H-2660, Hungary

Location

Szent János Kórház es Észak Budai Egyesitett Kórházak

Budapest, H-1023, Hungary

Location

Szent Margit Kórház

Budapest, H-1032, Hungary

Location

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

Budapest, H-1083, Hungary

Location

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

Budapest, H-1146, Hungary

Location

Debreceni Egyetem Klinikai Központ

Debrecen, H-4032, Hungary

Location

Pharmacy of The E. Wolfson Medical Center

Holon, 5810001, Israel

Location

The E. Wolfson Medical Center

Holon, 5810001, Israel

Location

Pharmacy of Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Saint George Hospital - University Medical Center

Beirut, Lebanon

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

Cebu Doctors' University Hospital

Cebu City, CEBU, 6000, Philippines

Location

Perpetual Succour Hospital

Cebu City, CEBU, 6000, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

Metropolitan Medical Center

Manila, 1003, Philippines

Location

University of Santo Tomas Hospital

Manila, 1008, Philippines

Location

St. Luke's Medical Center

Quezon City, 1102, Philippines

Location

Philippine Children's Medical Center

Quezon City, 1105, Philippines

Location

Centrul Medical Unirea

Bucharest, 013766, Romania

Location

Spitalul Clinic de Urgente pentru Copii "Sf. Maria"

Iași, 700309, Romania

Location

Nizhmedklinika

Nizhny Novgorod, Nizhny Novgorod Oblast, 603159, Russia

Location

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

Perm, Permskiy KRAY, 614000, Russia

Location

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

Moscow, 117997, Russia

Location

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

Moscow, 125412, Russia

Location

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

Perm, 614990, Russia

Location

LLC Medical Technologies

Saint Petersburg, 191025, Russia

Location

LLC Medical Technologies

Saint Petersburg, 192148, Russia

Location

St. Petersburg State Pediatric Medical University

Saint Petersburg, 194100, Russia

Location

"Baltiyskaya Medicyna" LLC

Saint Petersburg, 194356, Russia

Location

RSBHI Smolensk Regional Clinical Hospital

Smolensk, 214018, Russia

Location

SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev

Ulyanovsk, 432011, Russia

Location

SHI Central Clinical Medical Unit

Ulyanovsk, 432026, Russia

Location

SHI Central Clinical Medical Unit

Ulyanovsk, 432045, Russia

Location

MAI Children's City Clinical Hospital 9

Yekaterinburg, 620134, Russia

Location

Institute for Child and Youth Healthcare of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Mother and Child Healthcare Institute Dr Vukan Cupic

Belgrade, 11000, Serbia

Location

University Children's Hospital Belgrade

Belgrade, 11000, Serbia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Chang Gung Memorial Hospital- Kaohsiung branch

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Siriraj Hospital, Faculty of Medicine, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Phramongkutklao Hospital

Ratchathevee, Bangkok, 10400, Thailand

Location

Izmir Tepecik Training and Research Hospital

Izmir, Konak, 35120, Turkey (Türkiye)

Location

Eskisehir Osmangazi Universitesi Tip Fakultesi

Eskişehir, 26480, Turkey (Türkiye)

Location

Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

Trabzon, 61080, Turkey (Türkiye)

Location

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"

Dnipro, 49027, Ukraine

Location

Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

Dnipro, 49100, Ukraine

Location

Ivano-Frankivska oblasna dytiacha klinichna likarnia

Ivano-Frankivsk, 76018, Ukraine

Location

DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam

Kyiv, 04209, Ukraine

Location

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2

Uzhhorod, 88018, Ukraine

Location

Related Publications (1)

• Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.

  PMID: 32189338 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: September 16, 2014
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: January 20, 2021
• Results First Posted: October 9, 2018

Record last verified: 2018-09

Locations

BU (2); BE (1); RO (2); KR (2); DE (1); RU (14); TW (3); MY (1); GR (2); CN (3); ES (1); UA (5); TU (3); US (5); IL (4); SE (3); TH (2); FR (1); HU (6); LE (2); BO (1); PH (7)