Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

• Drug: Pregabalin
  
  Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
• Drug: Placebo
  
  Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.

• Active Comparator: Pregabalin
  
  The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.
  Intervention: Drug: Pregabalin
• Placebo Comparator: Placebo
  
  The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
  Intervention: Drug: Placebo

Inclusion Criteria:

• Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion Criteria:

• History of dementia or any other severe cognitive impairment
• Diabetic Peripheral Neuropathy (DPN)