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Table 1 Overview on clinical assessments for each study visit

From: An omics-based strategy using coenzyme Q10 in patients with Parkinson’s disease: concept evaluation in a double-blind randomized placebo-controlled parallel group trial

time (months) visit clinical assessments
−3-0 screening MDS-UPDRS III
Timed up and go test
10-m-walk test
vital signs
(safety) blood analyses
MDS-UPDRS I, II, and IV
PDQ39, BDI II, FSS, ESS, PDSS2, MoCA
informed consent
check of inclusion/exclusion criteria
0 start visit MDS-UPDRS III
Timed up and go test
10-m-walk test
vital signs
(safety) blood analyses
MDS-UPDRS I, II, and IV
PDQ39, BDI II, FSS, ESS, PDSS2, MoCA
MRI/MRSI
1 phone call 1 interview on AEs/SAEs, inquiry on self-ratings (diary cards)
2 phone call 2 interview on AEs/SAEs, inquiry on self-ratings (diary cards)
3 visit 1 MDS-UPDRS III
Timed up and go test
10-m-walk test
vital signs
(safety) blood analyses
MDS-UPDRS I, II, and IV
PDQ39, BDI II, FSS, ESS, PDSS2, MoCA
4 phone call 3 interview on AEs/SAEs, inquiry on self-ratings (diary cards)
5 phone call 4 interview on AEs/SAEs, inquiry on self-ratings (diary cards)
6 visit 2 (end of study treatment) MDS-UPDRS III
Timed up and go test
10-m-walk test
vital signs
(safety) blood analyses
MDS-UPDRS I, II, and IV
PDQ39, BDI II, FSS, ESS, PDSS2, MoCA
MRI/MRSI
9 follow-up visit MDS-UPDRS III
Timed up and go test
10-m-walk test
vital signs
(safety) blood analyses
MDS-UPDRS I, II, and IV
PDQ39, BDI II, FSS, ESS, PDSS2, MoCA
MRI/MRSI
  1. AE adverse event, BDI II Becks Depression Inventory II, ESS Epworth’s Sleepiness Scale, FSS Fatigue Severity Scale, MDS-UPDRS Movement Disorders Society Unified Parkinson’s Disease Rating Scale, MoCA Montreal Cognitive Assessment, MRI Magnetic Resonance Imaging, MRSI Magnetic Resonance Spectroscopy Imaging, PDQ39 Parkinson’s Disease Quality of Life Questionnaire (39 items), PDSS2 Parkinson’s Disease Sleep Scale 2, SAE serious adverse events