* BIA-91067-303 (EPSILON)
Research type
Research Study
Full title
A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label Extension The EPSILON Study: Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe
IRAS ID
298360
Contact name
Camille Carroll
Contact email
Sponsor organisation
BIAL- Portela & Cª, S.A.
Eudract number
2020-005011-52
Duration of Study in the UK
2 years, 10 months, 6 days
Research summary
A common drug given to people with PD (Parkinson's disease) is called levodopa (L-DOPA). It is often given in combination with another type of drug called a dopa decarboxylase inhibitor (DDCI). In the earlier stages of PD, L-DOPA is generally helpful in reducing symptoms. However, as PD progresses, L-DOPA can stop working as well as it did initially and patients can experience ‘motor fluctuations’, which are when the symptoms of PD may start coming back or are no longer fully controlled by L-DOPA.
Opicapone (the study drug) is an approved medication. It is intended to add to an L-DOPA/DDCI treatment regimen in patients with PD who experience motor fluctuations that cannot be controlled with L-DOPA/DDCI alone. However, the study drug is not yet approved for patients with earlier stage PD who do not experience motor fluctuations when receiving L-DOPA. As such, the study drug is ‘investigational’ for this purpose (meaning no regulatory agencies have approved its use).
This study aims to see whether the study drug may enhance the actions of L-DOPA in early stage PD. Participants will continue to take the treatment regimen of L-DOPA/DDCI that they are currently taking.
To check whether the study drug works, it will be compared with a placebo for part of the study. A placebo is a ‘dummy’ drug, which looks just like the study drug but contains no active medicine. Participants will have an equal chance (50/50) of being in one of the following two groups for approximately 6 months. Participants will not get to decide which study group they are in:
• Regular L-DOPA/DDCI treatment regimen, plus 50 mg study drug each day
• Regular L-DOPA/DDCI treatment regimen, plus placebo each day
After approximately 6 months, there will be a period of about 1 year in which everyone will receive the study drug for about 1 year.
Lay summary of study results: The lay summary will be prepared per the requirements.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0193
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion