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

Table 3 Overview of study assessments

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 medication^a
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 parameters^b

^aParacetamol or tramadol; ^bhaematology, serum biochemistry, pregnancy test
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

ISSN: 1471-2377