OpiCapone Effect on motor fluctuations and pAiN (OCEAN)
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain.
IRAS ID
283786
Contact name
Ray Chaudhuri
Contact email
Sponsor organisation
Bial - Portela & Ca, S.A.
Eudract number
2020-001175-32
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study plans to collect more information about how good opicapone is when treating patients with Parkinson's disease (PD) and pain that is due to PD. Patient’s pain due to their PD will be tested before given a treatment. Patients will have either 50mg opicapone or a placebo which will be taken once daily with the current treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI). They will take the treatment for the maximum of 24 weeks and during this time patient will complete a self-rated paper diary which will record whether they experience any PD related symptoms and pain. Once treatment is finished patients will have their final check.
REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/1021
Date of REC Opinion
16 Sep 2020
REC opinion
Favourable Opinion