The TOLEDO clinical trial was a phase III, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy and safety of apomorphine continuous infusion (CDI) in patients with advanced Parkinson’s disease (PD) experiencing motor fluctuations. The trial was conducted between 2014 and 2016 and involved 107 patients from 23 centers across Europe.

The primary endpoint of the trial was the change from baseline to week 12 in the percentage of “off” time (time when Parkinson’s symptoms are not adequately controlled) as measured by patient diaries. Secondary endpoints included changes in “on” time without troublesome dyskinesia, change in the Parkinson’s Disease Questionnaire-39 summary index score, and adverse events.

Patients were randomized to receive either apomorphine CDI or placebo for 12 weeks. The apomorphine CDI group received a subcutaneous infusion of apomorphine delivered via a pump for 24 hours a day for the duration of the study. The placebo group received a subcutaneous infusion of saline solution delivered via a pump for 24 hours a day for the duration of the study.

The results of the trial showed that the apomorphine CDI group had a significantly greater improvement in “off” time compared to the placebo group. The apomorphine CDI group also had a significantly greater increase in “on” time without troublesome dyskinesia and a greater improvement in quality of life as measured by the Parkinson’s Disease Questionnaire-39 summary index score.

The most common adverse events reported in the apomorphine CDI group were nausea, injection site reactions, and somnolence. Overall, the trial demonstrated that apomorphine CDI was an effective and well-tolerated treatment option for patients with advanced Parkinson’s disease