Pregabalin Versus Levetiracetam In Partial Seizures
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00537238
First received: September 27, 2007
Last updated: June 25, 2012
Last verified: June 2012
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Purpose
This study will compare pregabalin and levetiracetam 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 |
Drug: pregabalin Drug: levetiracetam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
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 percent 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 ]
| Enrollment: | 509 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: B |
Drug: pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
|
| Active Comparator: A |
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 epileptics 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
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Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00537238 History of Changes |
| Other Study ID Numbers: | A0081157 |
| Study First Received: | September 27, 2007 |
| Last Updated: | June 25, 2012 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios |
Keywords provided by Pfizer:
|
Epilepsies partial Partial Seizure Disorder Complex Partial Seizure Disorder Epilepsy |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Etiracetam Pregabalin Piracetam Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013