Cephalalgia : an international journal of headache
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Multicenter Study Clinical Trial
Patient-reported outcomes in subjects with painful trigeminal neuralgia receiving pregabalin: evidence from medical practice in primary care settings.
Effects of pregabalin (PGB) on patient-reported health outcomes were assessed in 65 PGB-naive subjects with trigeminal neuralgia refractory to previous analgesic therapy in a prospective, multicentre observational study carried out in primary care. Twelve weeks' monotherapy with PGB (n = 36) or add-on (n = 29), reduced baseline intensity of pain by a mean +/- S. D. of -40.0 +/- 22.1 mm [-55.4%, effect size (ES) 2.32; P < 0.0001] with 59.4% of responders (pain reduction >or= 50%), and produced 34.6 +/- 29.3 additional days with no/mild pain. ⋯ PGB improved sleep by -17.9 +/- 19.6 points (ES 1.18; P < 0.0001) and improved patient functioning (Sheehan Disability Index) by decreasing overall scoring by -8.6 +/- 5.9 points (ES 1.59; P < 0.0001). Health state (EQ-5D) increased by 31.6 +/- 22.2 mm (ES 1.67; P < 0.0001), with 0.0388 +/- 0.0374 gained quality-adjusted life-years. In spite of the small sample size, results support the effectiveness of PGB for the improvement in pain and related health symptoms.
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Randomized Controlled Trial Multicenter Study
Randomized, double-blind, placebo-controlled, proof-of-concept study of the cortical spreading depression inhibiting agent tonabersat in migraine prophylaxis.
Tonabersat is a novel putative migraine prophylactic agent with an unique stereospecific binding site in the brain. Tonabersat has been shown, in animal models, to inhibit experimentally induced cortical spreading depression, the likely underlying mechanism for migraine aura, and cerebrovascular responses to trigeminal nerve stimulation. The aim was to study the potential for tonabersat as a migraine preventive. ⋯ At least one treatment-emergent adverse event was reported in the tonabersat group in 61% of patients compared with 51% in the placebo group; none was worrisome. Placebo responses were unexpectedly high in this trial, complicating straightforward interpretation of the study results. The good tolerability and promising efficacy results support further exploration of higher doses of tonabersat in larger controlled trials.