Pregabalin Versus Levetiracetam In Partial Seizures - Full Text View

Purpose

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.

Condition	Intervention	Phase
Partial Seizures Epilepsies, Partial Partial Seizure Disorder Complex Partial Seizure Disorder Epilepsy	Drug: pregabalin Drug: levetiracetam	Phase III

Genetics Home Reference related topics:

autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

Drug Information available for:

Levetiracetam Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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). [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Change in frequency of secondarily generalized tonic-clonic seizures [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Brief Psychiatric Rating Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
MOS-Sleep Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Safety and tolerability; [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
Seizure free rate [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	570
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator	Drug: pregabalin 300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
A: Active Comparator	Drug: levetiracetam 1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537238

Contacts


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

Show 50 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081157
First Received:	September 27, 2007
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00537238
Health Authority:	Spain: Agencia Española del Medicamento y Productos Sanitarios

Study placed in the following topic categories:

Epilepsy, Complex Partial

Epilepsies, Partial

Signs and Symptoms

Epilepsy

Seizures

Pregabalin

Neurologic Manifestations

Central Nervous System Diseases

Etiracetam

Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents

Pathologic Processes

Disease

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Anticonvulsants

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00537238