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Table 3 Overview of study assessments

From: Opicapone versus placebo in the treatment of Parkinson’s disease patients with end-of-dose motor fluctuation-associated pain: rationale and design of the randomised, double-blind OCEAN (OpiCapone Effect on motor fluctuations and pAiN) trial

Category Assessment
Primary efficacy endpoint Change from baseline in Domain 3 (fluctuation-related pain) of KPPS
Key secondary endpoint Change from baseline in Domain B (anxiety) of MDS-NMS
Additional secondary endpoints Change from baseline in Domain A (depression) of MDS-NMS
Change from baseline in Domain K (sleep and wakefulness) of MDS-NMS
Change from baseline in MDS-NMS total score
Change from baseline in Domain 4 (nocturnal pain) of KPPS
Change from baseline in KPPS total score
Change from baseline in MDS-UPDRS Parts III and IV
Change from baseline in PDQ-8
CGI-C
PGI-C
Change from baseline in functional status via Hauser’s PD diary
Changes from baseline in morning dystonia
Use of rescue medicationa
Safety assessments Incidence of TEAEs, including serious TEAEs
Changes from baseline in vital signs
Changes from baseline in physical and neurological examinations
Changes from baseline in routine laboratory parametersb
  1. aParacetamol or tramadol; bhaematology, serum biochemistry, pregnancy test
  2. CGI-C Clinical Global Impression of Change, KPPS King’s Parkinson’s Disease Pain Scale, MDS-NMS Movement Disorder Society-sponsored Non-Motor rating Scale, MDS-UPDRS Movement Disorder Society-sponsored Unified Parkinson’s Disease Rating Scale, PD Parkinson’s disease, PDQ-8 8-item Parkinson’s Disease Questionnaire, PGI-C Patient’s Global Impression of Change, TEAE treatment-emergent adverse event