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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Pregabalin Versus Levetiracetam In Partial Seizures | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Partial Seizures | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 509 | |||
| Original Enrollment ICMJE | 400 | |||
| Actual Study Completion Date ICMJE | May 2012 | |||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium, Bulgaria, Colombia, Costa Rica, Czechia, France, Germany, Greece, India, Italy, Korea, Republic of, Lithuania, Mexico, Panama, Peru, Philippines, Russian Federation, Spain, Taiwan, Turkey, Venezuela | |||
| Removed Location Countries | Czech Republic | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00537238 | |||
| Other Study ID Numbers ICMJE | A0081157 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||