Evaluations
BLIND
The primary efficacy endpoint was change from predose to 90 min postdose in MDS-UPDRS Part III score after 4 weeks of dosing in each crossover period, assessed in clinic by a rater blinded to treatment assignment. The blind was maintained by ensuring that the rater did not witness in-clinic dosing, that visible injection sites were covered, and that source data and electronic clinical report forms were protected. Because SL-APO can leave a blue residue on the tongue, a sublingual placebo was administered upon SC-APO in-clinic dosing. Secondary endpoints were evaluated in a hierarchical order and included the following: investigator-rated durability of response (defined as investigator-confirmed achievement of a FULL ON within 30 min postdose and maintenance of that response at 90 min postdose); treatment preference for SL-APO, measured with a 9-item patient self-reported Treatment Preference Questionnaire (TPQ [Consort flow diagram. Pharmacokinetic (PK) concentration-time data for apomorphine and metabolites (apomorphine sulfate, norapomorphine) were evaluated and PK parameters, including maximum observed plasma concentration (CUnblinded safety evaluations conducted during both study phases included assessments of AEs, physical examinations, 12-lead electrocardiograms, and vital signs.