Pregabalin Versus Levetiracetam In Partial Seizures

Condition(s) targeted: Partial Seizures

Intervention: pregabalin (Drug); levetiracetam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This study will compare pregabalin and leveracitam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Official title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The primary outcome is efficacy - the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, as measured from baseline (data collected during 6 weeks).

Secondary outcome:

Change in seizure count frequency from baseline to endpoint, calculated as the % change in 28-day seizure frequency during the maintenance phase of treatment compared with baseline.

Change in frequency of secondarily generalized tonic-clonic seizures

Brief Psychiatric Rating Scale

Hospital Anxiety and Depression Scale

MOS-Sleep Scale

Safety and tolerability;

Seizure free rate

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy

with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.

- Partial seizures may be simple or complex, with or without secondary tonic-clonic

generalization.

- Subjects must be have been diagnosed with epilepsy for at least 2 years, and must

have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion Criteria:

- Females who are pregnant, breastfeeding, or intend to become pregnant during the

course of the trial will be excluded

- Subjects with other neurologic illness that could impair endpoint assessment, or

subjects with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Duffel B-2570, Belgium; Completed

Pfizer Investigational Site, Yvoir B-5530, Belgium; Completed

Pfizer Investigational Site, Kyustendil 2500, Bulgaria; Recruiting

Pfizer Investigational Site, Plovdiv 4000, Bulgaria; Recruiting

Pfizer Investigational Site, Ruse 7002, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1407, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1113, Bulgaria; Recruiting

Pfizer Investigational Site, San Jose, Costa Rica; Recruiting

Pfizer Investigational Site, Brno 602 00, Czech Republic; Recruiting

Pfizer Investigational Site, Brno 2 602 00, Czech Republic; Recruiting

Pfizer Investigational Site, Hradec Kralove 3 500 03, Czech Republic; Recruiting

Pfizer Investigational Site, Olomouc 775 20, Czech Republic; Recruiting

Pfizer Investigational Site, Ostrava-Trebovice 772 00, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 4 140 59, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 8 18000, Czech Republic; Not yet recruiting

Pfizer Investigational Site, Pribram 8 26195, Czech Republic; Recruiting

Pfizer Investigational Site, Rychnov nad Kneznou 516 01, Czech Republic; Recruiting

Pfizer Investigational Site, Strasbourg Cedex 67091, France; Recruiting

Pfizer Investigational Site, Toulouse 31043, France; Completed

Pfizer Investigational Site, Bonn 53105, Germany; Terminated

Pfizer Investigational Site, Hamburg 22083, Germany; Terminated

Pfizer Investigational Site, Athens 11521, Greece; Recruiting

Pfizer Investigational Site, Thessaloniki 57010, Greece; Recruiting

Pfizer Investigational Site, Firenze 50125, Italy; Recruiting

Pfizer Investigational Site, Foggia 71100, Italy; Recruiting

Pfizer Investigational Site, Pisa 56126, Italy; Recruiting

Pfizer Investigational Site, Siena 53100, Italy; Recruiting

Pfizer Investigational Site, Busan 602-715, Korea, Republic of; Recruiting

Pfizer Investigational Site, Daejeon 301-721, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 137-701, Korea, Republic of; Recruiting

Pfizer Investigational Site, Kaunas 50009, Lithuania; Recruiting

Pfizer Investigational Site, Vilnius 08661, Lithuania; Recruiting

Pfizer Investigational Site, Distrito Federal 14269, Mexico; Recruiting

Pfizer Investigational Site, San Luis Potosi 78223, Mexico; Recruiting

Pfizer Investigational Site, Panama, Panama; Recruiting

Pfizer Investigational Site, Lima L 11, Peru; Recruiting

Pfizer Investigational Site, Lima Lima 1, Peru; Recruiting

Pfizer Investigational Site, Cebu City 6000, Philippines; Recruiting

Pfizer Investigational Site, Davao City 8000, Philippines; Recruiting

Pfizer Investigational Site, Makati City 1200, Philippines; Recruiting

Pfizer Investigational Site, Manila 1000, Philippines; Recruiting

Pfizer Investigational Site, Quezon City 1100, Philippines; Recruiting

Pfizer Investigational Site, Moscow 129128, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 125367, Russian Federation; Terminated

Pfizer Investigational Site, Moscow 107150, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 194354, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 197022, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 194044, Russian Federation; Recruiting

Pfizer Investigational Site, Alicante 03010, Spain; Recruiting

Pfizer Investigational Site, Barcelona 08035, Spain; Terminated

Pfizer Investigational Site, Barcelona 08035, Spain; Recruiting

Pfizer Investigational Site, Cordoba 14008, Spain; Recruiting

Pfizer Investigational Site, Girona 17007, Spain; Recruiting

Pfizer Investigational Site, Sevilla 41071, Spain; Terminated

Pfizer Investigational Site, Kaohsiung 807, Taiwan; Recruiting

Pfizer Investigational Site, Taichung 407, Taiwan; Recruiting

Pfizer Investigational Site, Tainan 704, Taiwan; Recruiting

Pfizer Investigational Site, Ankara 06100, Turkey; Recruiting

Pfizer Investigational Site, Cerrahpasa / Istanbul 34098, Turkey; Recruiting

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Recruiting

Pfizer Investigational Site, Donostia, Guipuzcoa 20014, Spain; Completed

Pfizer Investigational Site, Capa, Istanbul 34390, Turkey; Recruiting

Pfizer Investigational Site, Caracas, Libertador 1010, Venezuela; Recruiting

Pfizer Investigational Site, Pune, Maharashtra 411 004, India; Recruiting

Pfizer Investigational Site, Tondo, Manila 1000, Philippines; Recruiting

Pfizer Investigational Site, Caracas, Miranda 1080-A, Venezuela; Terminated

Pfizer Investigational Site, Chandigarh, Punjab 160 012, India; Recruiting

Pfizer Investigational Site, Ludhiana, Punjab 141 008, India; Completed

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

Starting date: October 2007
Last updated: September 13, 2010