Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: A post hoc analysis

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity a randomized, double-blind Phase 3 study an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report post-hoc analysis the duration treatment effect. Subjects completing placebo-controlled main period (single injection cycle 12-20-week observation) entered OLEX received maximum five further treatments (maximum 69 weeks) at flexible intervals minimum 12 weeks, based on clinical need. Intervals between two consecutive injections, excluding prior to end-of-study visit, were evaluated. Of 437 intervals, 415 by 136 included analysis. More than half (52.3%; 217/415) all reinjections administered Week ≥14, 31.1% (129/415) ≥16, 19.0% (79/415) ≥18, 11.6% (48/415) ≥20. effect may vary can exceed 20 weeks or more, which observed least one 29.4% (40/136) over course their treatment. Data show that retreatment for not be required 12-week provides evidence beyond this time frame.