Conditions: Central Neuropathic Pain
Keywords: Post-stroke pain, pregabalin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: