Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial

This study is registered with ClinicalTrials.gov (NCT02006121).FindingsBetween March 3, 2014, and March 1, 2016, 128 patients were screened for eligibility and 107 were randomly assigned, of whom 106 were included in the full analysis set (n=53 in both groups). Apomorphine infusion (mean final dose 4·68 mg/h [SD 1·50]) significantly reduced off time compared with placebo (−2·47 h per day [SD 3·70] in the apomorphine group vs −0·58 h per day [2·80] in the placebo group; difference −1·89 h per day, 95% CI −3·16 to −0·62; p=0·0025). Apomorphine was well tolerated without any unexpected safety signals. Six patients in the apomorphine group withdrew from the study because of treatment-related adverse events.InterpretationApomorphine infusion results in a clinically meaningful reduction in off time in patients with Parkinson's disease with persistent motor fluctuations despite optimised oral or transdermal therapy.FundingBritannia Pharmaceuticals.
Source: The Lancet Neurology - Category: Neurology Source Type: research