Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002754-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.
The study consists of a one-week screening period, four weeks of open-label treatment and two weeks of post-study follow-up. The total study duration for each patient will be approximately 7 weeks
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg opicapone once-daily | Experimental |
| |
| 100 mg of L-DOPA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opicapone | Drug | 50 mg hard capsules. Oral administration, once-daily at bedtime, at least 1 hour before or after L-DOPA/carbidopa or benserazide (L-DOPA/DDCI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Absolute OFF-time from baseline to end of study | OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. | up to 7 weeks |
| Proportion of patients with one hour or more reduction in Absolute OFF-time from baseline to end of study (OFF-time responders) | OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. | up to 7 weeks |
| Change in Absolute ON-time from baseline to end of study | ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness. | up to 7 weeks |
| Proportion of patients with one hour or more increase in Absolute ON-time from baseline to end of study (ON-time responders) | ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness. | up to 7 weeks |
| Change in Percentage OFF-time between baseline and end of study | OFF = Time when medication has worn off and is no longer providing benefit with regard | up to 7 weeks |
| Change in Percentage ON-time between baseline and end of study | ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness. | up to 7 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | ||
| Parkinson-Klinik Ortenau GmbH&Co KG |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| L-DOPA/DDCI | Drug | L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration |
|
|
| Wolfach |
| Baden-Wurttemberg |
| 77723 |
| Germany |
| Klinik Haag i. OB | Haag in Oberbayern | Bavaria | 83527 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | Bavaria | 97080 | Germany |
| Praxis Dr. Oehlwein | Gera | Thuringia | 07551 | Germany |
| Asklepios Fachklinikum Stadtroda | Stadtroda | Thuringia | 07646 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Praxis Dr. med. Kirsten Hahn | Berlin | 13187 | Germany |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Azienda Ospedaliera Santa Maria di Terni | Terni | 05100 | Italy |
| Hospital Beatriz Ângelo | Loures | Lisbon District | 2674-514 | Portugal |
| CNS-Campus Neurologico Senior | Torres Vedras | Lisbon District | 2560-280 | Portugal |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital de Sant Joan Despi Moises Broggi | Sant Joan Despí | Barcelona | 08041 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | La Coruña | 15006 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Complejo Hospitalario Universitario de Orense | Ourense | 32005 | Spain |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | Devon | EX2 5DW | United Kingdom |
| University Hospitals Plymouth | Plymouth | Devon | PL6 8DH | United Kingdom |
| King's College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| Newcastle University- Clinical Ageing Research Unit | Newcastle upon Tyne | Tyne & Wear | NE4 5PL | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549349 | opicapone |
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
Not provided
Not provided