Safety and efficacy of botulinum toxin A in patients with trigeminal neuralgia: a double-blind, randomized, placebo-controlled, parallel-group trial and investigation of neuro-inflammatory biomarkers as predictors of efficacy

Trigeminal neuralgia

The proportion of responders in botulinum toxin A (BTX-A) and placebo group during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1) (see protocol for definition of responders).

The degree of change in inflammatory biomarkers in responders versus non-responders in BTX-A and placebo group., The difference in inflammatory biomarkers between the symptomatic side and the asymptomatic side., The proportion of subjects reaching ≥50% reduction in mean ADP during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1)., The proportion of subjects reaching ≥75% reduction in mean ADP during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1)., The proportion of subjects reaching ≥30% reduction in mean ADP during week 9 to 12 compared with baseline (week -4 to -1)., Change in mean number of daily pain paroxysms during the evaluation period (week 2 to 5) and week 9 to 12 compared with baseline (week -4 to -1) in BTX-A and placebo group., Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 5 in BTX-A group and placebo group., Change from baseline to week 5 in the PENN-FPS-R score in BTX-A and placebo group., Proportion of subjects correctly guessing whether they received BTX-A or placebo., Proportion of dropouts caused by increased intake of trigeminal neuralgia medication or use of prohibited rescue medication in botulinum toxin A group compared to the placebo group., Proportion of subjects with side-effects registered in weeks 2 to 5 during treatment with botulinum toxin A compared with placebo

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