Health Condition 1: null- Partial Seizures Epilepsies, Partial
Conditions
Interventions
Intervention1: pregabalin CR 330 mg: Experimental Interventions:
1. Drug: pregabalin
2. Drug: pregabalin
3. Drug: pregabalin
4. Drug: pregabalin
: 1. Drug: pregabalin
Controlled Release Tablets,
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure) 2. Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs . subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study
Exclusion criteria
Exclusion criteria: 1. Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome) 2. Status epilepticus within one year prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phaseTimepoint: Week 0 to week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessmentTimepoint: Screening to Week 15;2. Responder rate (proportion of subjects who have a greater than or equal to 50% reduction in partial seizure rate from baseline during the double blind maintenance treatment phase compared to the 8 week baseline (screening) seizure phase).Timepoint: Screening to Week 15;3. The percentage change in 28 day partial seizure rates summarized by treatment groupTimepoint: Screening to Week 15;4. Frequency of secondary generalized tonic clonic seizures (SGTC).Timepoint: Screening to Week 15;5. Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind maintenance treatment phase.Timepoint: Screening to Week 15;6. SGTC responder rate.Timepoint: Screening to Week 15;7. Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores.Timepoint: Baseline to Week 14;8. Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores.Timepoint: Baseline to Week 14;9. Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW).Timepoint: Baseline to Week 14 | — |
Countries
Argentina, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Germany, Hungary, India, Malaysia, Mexico, Other, Poland, Romania, Russian Federation, Serbia, Singapore, Thailand, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed