Procedures
Parkinson’s disease, movement disorder
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, MOVEMENT DISORDER, MOVEMENT DISORDER
At screening for trial entry, candidates underwent physical and neurological examination. Enrolled participants were assessed by physical visits by a movement disorder specialist at baseline (visit 1, V1), day 7 (V4), day 14 (V5), day 21 (V6) and day 28 (V7). At baseline and day 28 participants underwent additional assessment with the Movement Disorder Society Unified Parkinson’s disease Rating Scale section I-IV (MDS-UPDRS). At all physical visits an electrocardiogram (ECG), vital parameters (blood pressure, pulse, weight, height) and blood samples were obtained. Additional blood samples were taken on day 3 (V2) and day 5 (V3) to assess safety. Flash frozen whole blood samples for metabolite analyses (NADMed and LC-MS) were obtained by collecting blood in EDTA tubes, aliquoting into 250µl aliquots and snap freezing the tubes in liquid nitrogen precisely 2 min after blood was drawn. The participants were interviewed by telephone consultation by a study nurse on day 3 and day 35 to screen for additional adverse events. Participants were instructed to take their anti-Parkinson drugs as they normally would and no changes were made to anti-Parkinson drug treatment during the trial. Adverse events (AEs) were recorded by the investigating physician. These were then classified by severity according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)