Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
NCT00524030
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- Diagnosis of epilepsy with partial seizures.
- Males or females, age 18 years or older.
- Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
- Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.
- Current diagnosis of febrile seizures or seizures related to an ongoing acute medical
event.
- Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or
infectious origin.
- Primary generalized epilepsy or status epilepticus within the previous year.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures | |||
Official Title ICMJE | A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures | |||
Brief Summary | This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months. | |||
Detailed Description | After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011. | |||
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 | Epilepsies, Partial | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | French J, Kwan P, Fakhoury T, Pitman V, DuBrava S, Knapp L, Yurkewicz L. Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial. Neurology. 2014 Feb 18;82(7):590-7. doi: 10.1212/WNL.0000000000000119. Epub 2014 Jan 10. | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE | 161 | |||
Original Enrollment ICMJE | 250 | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Czechia, Hong Kong, Ukraine, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00524030 | |||
Other Study ID Numbers ICMJE | A0081047 | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |