The design for two new trials investigating opicapone in the treatment of non-motor symptoms in patients with motor fluctuations in Parkinson’s disease (PD) have been presented at the International Parkinson and Movement Disorder Society’s Virtual Congress (MDS Virtual Congress 2021).
Usually associated with motor symptoms, opicapone is a once-daily catechol-O-methyltransferase (COMT) inhibitor, approved in Europe for the treatment of end-of-dose motor fluctuations in adult PD patients on L-dopa/ DDCI therapy.3 Two new studies have been developed to investigate the impact of opicapone on PD-associated sleep disorders and motor fluctuation-associated pain.1,2
PD is generally considered a disease that affects movement, however non-motor symptoms are common, diverse and can be more disabling than movement-related motor symptoms.4 A study showed that non-motor symptoms are frequent during all stages of PD patients and common reported symptoms were fatigue, pain, and sleep disturbance.5 Non-motor symptoms can have a substantial impact on health-related quality-of-life. Such symptoms are reported in about 90% of idiopathic PD patients.6
The OCEAN (OpiCapone Effect on motor fluctuations and associated pain) study is a randomised, double-blind, placebo-controlled trial and will investigate the effect of opicapone as an adjunct treatment to L-dopa/DDCI on motor fluctuations-associated pain. Patients will be randomised to receive either opicapone once daily or placebo over 24 weeks.1
A further new open-label, single-arm, pilot trial, OASIS (OpicApone in Sleep dISorder), will similarly assess the impact of opicapone once-daily alongside L-dopa/DDCI therapy, on PD-associated sleep disorders over a six-week evaluation period.2
Lead author for the OCEAN study, Professor K Ray Chaudhuri, Medical Director of the Parkinson Foundation International Centre of Excellence at King’s College, London, commented, “The impact of non-motor symptoms on the quality of life of PD patients remains significant and it is important that patients are treated appropriately. We are pleased to share the design for this study exploring the potential for opicapone as an adjunct treatment for non-motor symptoms and we look forward to sharing our findings.”
Dr Raquel Costa, Senior Clinical Research Manager at BIAL and lead author for the OASIS study, commented “End-of-dose motor fluctuations and associated sleep disorders are commonly observed in PD patients undergoing treatment with L-dopa/ DDCI.2 We look forward to investigating whether opicapone could help improve such symptoms in the OASIS study.”
- Chaudhuri KR et al. The OCEAN (OpiCapone Effect on motor fluctuations and associated pAiN) study in Parkinson’s disease: design and rationale or a randomized double-blind placebo-controlled trial. MDS Virtual Congress 2021. Abstract No. 373.
- Costa R et al. The OASIS (OpicApone in Sleep dISorder) study in Parkinson’s disease: design and rationale of an open-label, single-arm, pilot trial. MDS Virtual Congress 2021. Abstract No. 376
- Ongentys® EU SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_en.pdf Last accessed September 2021.
- Non-movement symptoms. Parkinson’s Foundation. Available at: https://www.parkinson.org/Understanding-Parkinsons/Non-Movement-Symptoms Last accessed September 2021
- Gökçal et al., Motor and Non-Motor Symptoms in Parkinson’s Disease: Effects on Quality of Life. Noro Psikiyatr Ars.2017;54(2):143-148.
- Chaudhuri KR, et al. Parkinson’s disease: The non-motor issues. Parkinsonism Relat Disord 2011;17: 717-723.