Clinical Study With Lyrica In Patients Suffering From Epilepsy

• Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency [ Time Frame: Baseline through week 16 or early termination (ET) ] [ Designated as safety issue: No ]
  Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.
  
  

• Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit [ Time Frame: Baseline and week 16 or ET ] [ Designated as safety issue: No ]
  The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.
  
  
• Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study [ Time Frame: Week 4 through week 16 or ET ] [ Designated as safety issue: No ]
  Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.
  
  
• Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit [ Time Frame: Baseline, week 4 and week 16 or ET ] [ Designated as safety issue: No ]
  VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
  
  
• Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  
  
• Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit [ Time Frame: Week 16 or ET ] [ Designated as safety issue: No ]

  The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).

  At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.

  
  
• Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET [ Time Frame: Baseline and week 16 or ET ] [ Designated as safety issue: No ]
  MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.
  
  

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).