Partial Siezures MedDRA version: 12.1 Level: LLT Classification code 10061334 Term: Partial seizures
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must have met the inclusion criteria for Protocol A0081047, have completed the monotherapy phase (Week 20) of Protocol A0081047 and wish to receive open-label pregabalin; 2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 3. Minimum body weight of 90 lbs. 4. Must continue to use adequate birth control methods and have a negative pregnancy test at Screening (for females of childbearing potential only); 5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Exited Protocol A0081047 by experiencing one of the following predetermined exit criteria for that study: 2. An episode of status epilepticus; 3. A secondarily generalized tonic-clonic seizure if none had been experienced within 2 years of study entry; 4. A 28-day study seizure rate during the A0081047 double-blind treatment phase that was greater than two times the maximum 28-day study seizure rate during the A0081047 Baseline Phase (a 28-day period is defined as 28 consecutive study days); 5. A 2-day study seizure rate during the A0081047 double-blind treatment phase that was greater than two times the maximum 2-day study seizure rate during the A0081047 Baseline Phase (a 2-day period is defined as 2 consecutive study days); 6. An unacceptable increase in the frequency or intensity of seizure activity that, according to the investigator, is clinically significant. 7. Have primary generalized epilepsy (eg, absence epilepsy); 8. Have Lennox-Gastaut Syndrome; 9. Have had status epilepticus during the previous study (Protocol A0081047); 10. Are pregnant or are considering becoming pregnant; 11. Are receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency; 12. Have a WBC count <2500/mm3, a neutrophil count <1500/mm3, or a platelet count <100,000/mm3; 13. Have a creatinine clearance =60 mL/min (estimated from serum creatinine); 14. Have a significant psychiatric disorder or episode of severe depression during the previous study, Protocol A0081047. Patients with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable; 15. Experienced a serious adverse event during Protocol A0081047, which was determined to be related (possibly, probably, or definitely) to study medication by the investigator or Pfizer medical monitor; 16. Participation in studies (other than Protocol A0081047) within 6 months before the current study begins and/or during study participation 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and efficacy of open-label pregabalin administered as monotherapy at dosages of 150 to 600 mg/day (administered BID) in patients with partial seizures who responded to treatment and completed Protocol A0081047.;Secondary Objective: There are no secondary objectives, just the one main objective in E.2.1;Primary end point(s): Long term safety and efficacy of pregabalin during open-label administration will be assessed based on the nature, incidence and severity of adverse events and clinical laboratory findings, and on the seizure diary data, respectively. | — |
Countries
Czech Republic
Outcome results
None listed