Once-A-Day Pregabalin For Partial Seizures

NCT01262677 | Completed Phase 3 Results DMC

• 2 other identifiers: A00811942010-019035-35
• Study Type: interventional
• Target: 325
• Locations: 18 countries
• Sites: 82

Brief Summary

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Conditions

Partial Seizures; Epilepsies, Partial

Keywords

Partial epilepsy; partial seizures; epilepsy; seizures; adjunctive therapy; intervention; controlled-release; placebo-controlled; seizure

Outcome Measures

Primary Outcomes (1)

• Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase

  Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.

  Week 0 to Week 14

Secondary Outcomes (27)

• Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase

  Week 0 to Week 14

• Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase

  Week 0 to Week 14

• Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase

  Week 0 to Week 14

• Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase

  Week 2 to Week 14

• Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase

  Week 0 to Week 14

Study Arms (3)

pregabalin CR 330 mg

EXPERIMENTAL

Drug: pregabalin

pregabalin CR 165 mg

EXPERIMENTAL

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

pregabalin DRUG

Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days

pregabalin CR 330 mg

placebo DRUG

matched to the active drug

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
• Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

You may not qualify if:

• Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
• Status epilepticus within one year prior to screening

Sponsors & Collaborators

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

Study Sites (82)

Neurology Clinic, PC

Northport, Alabama, 35476, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Collaborative Neuroscience Network, Inc.

Long Beach, California, 90806, United States

Location

Viking Clinic Research Center

Murrieta, California, 92562, United States

Location

Viking Clinical Research Center

Murrieta, California, 92562, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Viking Clinical Research Center

Temecula, California, 92591, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Optima Neurological Services, LLC

Gainesville, Florida, 32608, United States

Location

Sleep Disorders Center of Georgia - Gainesville

Gainesville, Georgia, 30501, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

VCMA Comprehensive Epilepsy Center

Wichita, Kansas, 67214, United States

Location

Via Christi Research

Wichita, Kansas, 67214, United States

Location

Associates in Neurology, PSC

Lexington, Kentucky, 40513, United States

Location

Mid Atlantic Headache Institute

Pikesville, Maryland, 21208, United States

Location

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Mark A. Fisher, M.D.- Private Practice

Oklahoma City, Oklahoma, 73112, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Veroniqe Sebastian, MD

Oklahoma City, Oklahoma, 73120, United States

Location

Angelique Barreto, MD

Oklahoma City, Oklahoma, 73135, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Scott and White Healthcare-Office of Sponsored Research Administration

Temple, Texas, 76502, United States

Location

Scott & White Healthcare

Temple, Texas, 76508, United States

Location

Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)

Buenos Aires, C1117ABE, Argentina

Location

Clinic of Neurology,Clinical Centar University Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

MBAL Puls AD, Nevrologichno otdelenie

Blagoevgrad, 2700, Bulgaria

Location

UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika

Pleven, 5800, Bulgaria

Location

DKTs Akta Medika, Konsultativen kabinet po Nevrologiya

Sevlievo, 5400, Bulgaria

Location

MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,

Sofia, 1113, Bulgaria

Location

Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie

Sofia, 1202, Bulgaria

Location

Litomyslská nemocnice, a.s.

Litomyšl, 570 14, Czechia

Location

Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP

Prague, 140 59, Czechia

Location

Neurologicka ambulance

Prague, 160 00, Czechia

Location

Epilepsie-Zentrum Bethel

Bielefeld, 33617, Germany

Location

Praxis fuer Neurologie und Psychiatrie, Psychotherapie

Bielefeld, 33647, Germany

Location

Klinik fuer Epileptologie, Universitaet Bonn

Bonn, 53105, Germany

Location

Neuro Consil GmbH

Düsseldorf, 40212, Germany

Location

Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork

Kehl-Kork, 77694, Germany

Location

Studienzentrum Dr. Stephan Arnold

München, 80638, Germany

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Department of Medicine, Queen Elizabeth Hospital

Kowloon, 0, Hong Kong

Location

Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly

Balassagyarmat, 2660, Hungary

Location

Synexus Magyarorszag Kft.

Budapest, 1036, Hungary

Location

Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly

Budapest, 1145, Hungary

Location

Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly

Dunaújváros, 2400, Hungary

Location

Lalitha Super Specialities Hospital (P) Ltd.

Guntur, Andhra Pradesh, 522 001, India

Location

Jagadguru Sri Shivathreeshwara Medical College and Hospital,

Mysore, Karnataka, 570004, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411 004, India

Location

Sahyadri Clinical Research & Development Center,

Pune, Maharashtra, 411 004, India

Location

KEM Hospital Research Centre

Pune, Maharashtra, 411 011, India

Location

Sahyadri Speciality Hospital

Pune, Maharashtra, 411004, India

Location

Poona Hospital and Research Centre Department of Neurology

Pune, Maharashtra, 411030, India

Location

Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,

Nehru Nagar, NEW Delhi, 110 065, India

Location

Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Hospital Universiti Sains Malaysia

Kelantan Darul Naim, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Private Office 201

Delagación Cuauhtemoc, Mexico City, 06700, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, CP 64460, Mexico

Location

Hospital Angeles Culiacan

Culiacán, Sinaloa, 80020, Mexico

Location

Instituto Biomedico de Investigacion A. C.

Aguascalientes, 20127, Mexico

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Gdansk, 80-266, Poland

Location

Centrum Neurologii Klinicznej Sp. z o. o.

Krakow, 31-505, Poland

Location

Gabinet Lekarski A. Klimek

Lodz, 90-148, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska

Świdnik, 21-040, Poland

Location

Epilepsy Control Institute

San Juan, PR, 00923, Puerto Rico

Location

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

Iași, JUD. IASI, 700309, Romania

Location

Cabinet Medical Individual " Dr. Adina Maria Roceanu"

Bucharest, 010042, Romania

Location

Municipal Healthcare Institution City Hospital #5, Neurology Department

Barnaul, 656045, Russia

Location

State Medical Institution Republican Clinical Hospital

Kazan', 420064, Russia

Location

Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation

Moscow, 107150, Russia

Location

Pyatigorsk City Hospital #2, Neurology Department,

Pyatigorsk, 357538, Russia

Location

State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav

Saint Petersburg, 192019, Russia

Location

Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department

Samara, 443095, Russia

Location

Institute for Mental Health

Belgrade, 11 000, Serbia

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Neurology Division, Department of Medicine, Pramongkutklao College of Medicine

Bangkok, 10400, Thailand

Location

Related Publications (1)

• French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.

  PMID: 24962242 DERIVED

Related Links

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

MeSH Terms

Conditions

Seizures; Epilepsies, Partial; Epilepsy

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: February 17, 2011
• Primary Completion: July 31, 2012
• Study Completion: August 1, 2012
• Last Updated: January 25, 2021
• Results First Posted: June 6, 2018

Record last verified: 2018-04

Locations

MY (3); TH (2); CZ (3); ME (5); IN (8); RO (2); HK (2); US (26); DE (6); HU (4); PR (1); RU (6); SG (2); BO (1); AR (1); PL (4); BU (5); SE (1)