Opicapone

Generic Name
Opicapone
Brand Names
Ongentys, Ontilyv
Drug Type
Small Molecule
Chemical Formula
C15H10Cl2N4O6
CAS Number
923287-50-7
Unique Ingredient Identifier
Y5929UIJ5N
Background

Opicapone is a potent, reversible, and peripherally-acting third-generation inhibitor of catechol-o-methyltransferase (COMT), an enzyme involved in the breakdown of various catecholamines including dopamine. Many patients with Parkinson’s disease treated with levodopa plus a dopa decarboxylase (DDC) inhibitor (eg carbidopa) experience motor complications ove...

Indication

Opicapone is indicated as adjunctive therapy in adults with Parkinson’s disease and end-of-dose motor fluctuations or “off” episodes whose symptoms cannot be stabilized on the combination therapy of levodopa and DOPA decarboxylase inhibitor (e.g., carbidopa).

Associated Conditions
Parkinson's Disease (PD)
Associated Therapies
-

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-08-04
Last Posted Date
2023-04-13
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
106
Registration Number
NCT04990284
Locations
🇵🇹

Hospital Beatriz Ângelo, Loures, Lisboa, Portugal

🇮🇹

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milano, Italy

🇮🇹

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", Napoli, Italy

and more 22 locations

OpicApone Sleep dISorder

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-08-03
Last Posted Date
2023-04-14
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
22
Registration Number
NCT04986995
Locations
🇵🇹

Hospital da Senhora da Oliveira - Guimarães, E.P.E, Serviço de Neurologia, Guimarães, Portugal

Opicapone Treatment Initiation Open-Label Study

Completed
Conditions
Interventions
First Posted Date
2021-03-09
Last Posted Date
2022-11-28
Lead Sponsor
Neurocrine Biosciences
Target Recruit Count
239
Registration Number
NCT04787965
Locations
🇺🇸

Neurocrine clinical site, Crab Orchard, West Virginia, United States

Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

First Posted Date
2019-05-22
Last Posted Date
2021-10-04
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
39
Registration Number
NCT03959540
Locations
🇬🇧

Norfolk&Norwich University Hospitals, Norwich, Norfolk, United Kingdom

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-04-12
Last Posted Date
2019-03-22
Lead Sponsor
Neurocrine Biosciences
Target Recruit Count
16
Registration Number
NCT03496870
Locations
🇺🇸

Neurocrine Clinical Site, Farmington Hills, Michigan, United States

Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-05-13
Last Posted Date
2020-03-16
Lead Sponsor
Rabin Medical Center
Target Recruit Count
1
Registration Number
NCT01851850
Locations
🇮🇱

Rabin Medical Center, Petach Tiqva, Hamerkaz, Israel

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