Levetiracetam in patients with central neuropathic post-stroke pain – a randomized, double-blind, placebo-controlled trial
Correspondence: G. J. Jungehulsing, MD, Department of Neurology and Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203 Berlin, Germany (tel.: +49 (0)30 84454080/4145; fax: +49 (0)30 84454264; e-mail: firstname.lastname@example.org).
Background and purpose
Central post-stroke pain (CPSP) is a severe chronic neuropathic pain condition defined as a spontaneous pain or allodynia corresponding to a vascular lesion. It usually evolves weeks after stroke, and can distinctively impair the quality of life. Treatment is complex and mostly unsatisfactory. We hypothesized that the anti-epileptic drug levetiracetam (LEV) improves CPSP compared with placebo. The purpose of this study was to examine the efficacy and tolerability of LEV in patients with CPSP.
In a double-blind, placebo-controlled, crossover study design patients with CPSP lasting at least 3 months and a pain score ≥ 4 on the 11-point Likert scale were treated over two 8-week periods with a maximum dose up to 3000 mg LEV or placebo. Primary endpoint was a median pain lowering ≥ 2 in the final treatment week compared with the last baseline week. Secondary outcome measures comprised additional pain ratings, depression, sleep quality, quality of life and patients' global impression of change.
Of 42 patients, 33 [61.5 years (40–76); 38% women] completed the study. Side effects and withdrawals were more frequent in the LEV (n = 5) group than in the placebo group (n = 1). Patients treated with LEV did not show any improvement of pain or changes in secondary outcome parameters compared with placebo.
LEV is not effective in treatment for CPSP. The mode of action of LEV does not exert an analgesic effect in chronic CPSP.