Epilepsy Clinical Trial
Official title:
An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
| NCT number | NCT00596466 |
| Other study ID # | A0081160 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | April 2008 |
| Est. completion date | December 2011 |
| Verified date | August 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Completed the previous protocol and wish to continue to receive pregabalin. - Diagnosis of epilepsy with partial seizures Exclusion Criteria: - Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Pfizer Investigational Site | Beroun | |
| Czechia | Pfizer Investigational Site | Brno 2 | |
| Czechia | Pfizer Investigational Site | Litomysl | |
| Hong Kong | Pfizer Investigational Site | New Territories | |
| Ukraine | Pfizer Investigational Site | Dnipropetrovsk | |
| Ukraine | Pfizer Investigational Site | Dnipropetrovsk | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Lugansk | |
| Ukraine | Pfizer Investigational Site | Odessa | |
| United States | Pfizer Investigational Site | Bowling Green | Kentucky |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Danville | Indiana |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Fayetteville | Arkansas |
| United States | Pfizer Investigational Site | Flowood | Mississippi |
| United States | Pfizer Investigational Site | Fort Wayne | Indiana |
| United States | Pfizer Investigational Site | Fullerton | California |
| United States | Pfizer Investigational Site | Great Falls | Montana |
| United States | Pfizer Investigational Site | Houma | Louisiana |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Long Beach | California |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Modesto | California |
| United States | Pfizer Investigational Site | Murrieta | California |
| United States | Pfizer Investigational Site | Newport Beach | California |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Pikesville | Maryland |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Shreveport | Louisiana |
| United States | Pfizer Investigational Site | Suwanee | Georgia |
| United States | Pfizer Investigational Site | Temecula | California |
| United States | Pfizer Investigational Site | Temple | Texas |
| United States | Pfizer Investigational Site | West Jordan | Utah |
| United States | Pfizer Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Czechia, Hong Kong, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Seizure Frequency | Baseline up to Week 28 | ||
| Primary | Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to Week 28 | |
| Primary | Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. | Baseline up to Week 28 |
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