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

• Pain Score as Measured by DPRS [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ] [ Designated as safety issue: No ]
• Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
• Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
• Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS]) [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ] [ Designated as safety issue: No ]
• Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Medical Outcome Study (MOS) Sleep Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Hospital Anxiety and Depression Scale (HADS) - ITT Population [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• EQ-5D - VAS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Clinical Global Impression of Change (CGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
• QANeP - Pain Rating Scales [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

• Weekly mean pain score from Daily Pain Diary
• Proportion of subjects with at least a 30% and 50% reduction in mean pain score at endpoint as compared with baseline
• Quantitative Assessment of Neuropathic Pain (QANeP)
• Neuropathic Pain Symptom Inventory (NPSI-symptoms of NeP; Bouhasira et al. in Pain, 2004)
• Weekly mean sleep interference score from Daily Sleep Diary
• Medical Outcome Study (MOS) Sleep ScaleHospital Anxiety and Depression Scale (HADS)
• Short Form-McGill Pain Questionnaire, [SF-MPQ (VAS)]-Part B only.EuroQOL (EQ-5D)
• Health State Profile and Visual Analogue Scale (VAS).
• Clinical Global Impression of Change (CGIC)
• Patient Global Impression of Change (PGIC)
• Safety and tolerability as measured by the assessment of adverse events,
• vital signs, physical and neurological examinations,
• clinical laboratory tests and electrocardiogram.

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

• 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)