Once-A-Day Pregabalin For Partial Seizures

• Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: Yes ]
• 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 treatment phase compared to the 8 week baseline (screening) seizure phase). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• The percentage change in 28 day partial seizure rates summarized by treatment group. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Frequency of secondary generalized tonic clonic seizures (SGTC). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind treatment phase. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• SGTC responder rate. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
• Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
• Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW). [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

• Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: Yes ]
• 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). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• The percentage change in 28 day partial seizure rates summarized by treatment group. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Frequency of secondary generalized tonic clonic seizures (SGTC). [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind maintenance treatment phase. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• SGTC responder rate. [ Time Frame: Screening to Week 15 ] [ Designated as safety issue: No ]
• Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
• Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores. [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
• Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW). [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

• Partial Seizures
• Epilepsies, Partial

• Drug: pregabalin
  Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
• Drug: pregabalin
  Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
• Drug: pregabalin
  Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
• Drug: pregabalin
  Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
• Drug: pregabalin
  Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
• Drug: placebo
  matched to the active drug

• Experimental: pregabalin CR 330 mg
  Interventions:

  • Drug: pregabalin
  • Drug: pregabalin
  • Drug: pregabalin
  • Drug: pregabalin
• Experimental: pregabalin CR 165 mg
  Interventions:

  • Drug: pregabalin
  • Drug: pregabalin
• Placebo Comparator: Placebo
  Intervention: Drug: placebo

Inclusion Criteria:

• Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
• Currently taking 1 to 3 anit-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

• Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
• Status epilepticus within one year prior to screening