eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.
NCT ID: NCT04990284
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
106 participants
INTERVENTIONAL
2021-11-29
2023-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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50 mg opicapone once-daily
Opicapone
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).
100 mg of L-DOPA
L-DOPA/DDCI
L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration
Interventions
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Opicapone
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).
L-DOPA/DDCI
L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients aged 30 years or older.
3. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
4. Disease severity Stages I-III (Hoehn \& Yahr staging) at ON.
5. Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600 mg L-DOPA.
6. In case of any other anti-PD-treatments, they should be on a stable regimen for at least four weeks before screening, and not likely to need any adjustment during the study.
7. Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), despite optimal anti-PD therapy (based on Investigator's assessment).
8. Experiencing wearing-off phenomenon for at least 4 weeks but less than 2 years prior to screening.
9. For females: Postmenopausal for at least 2 years before screening, surgically sterile for at least 6 months before screening, or practicing effective contraception until the post-study visit. Female patients who request to continue with oral contraceptives must be willing to use non-hormonal methods of contraception in addition during the course of this study.
10. Have filled-in self-rating diary charts in accordance with the diary chart instructions and with ≤3 errors per day while awake, in the three consecutive days preceding randomization.
11. With at least 1 hour at OFF state per day, including the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in at least two of the three-day self-rating diary charts for the three days preceding randomization.
12. Adequate compliance to relevant concomitant medication during the period between V1 and V2 (based on the Investigator's judgment).
Exclusion Criteria
2. Severe and/or unpredictable OFF periods, according to Investigator's judgment.
3. Average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).
4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last 4 weeks before screening.
5. Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
6. Previous or current use of opicapone or L-DOPA/carbidopa intestinal gel infusion.
7. Use of any other investigational product (IP), currently or within the 3 months (or within 5 half-lives of the IP, whichever is longer) before screening.
8. Past (within the past year) or present history of suicidal ideation or suicide attempts.
9. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
10. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
11. Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
12. History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
13. History of severe hepatic impairment (Child-Pugh Class C).
14. Current or previous (within the past year) diagnosis of psychosis, severe major depression or other psychiatric disorders that, based on the Investigator's judgment, might place the patient at increased risk or interfere with assessments.
15. Any medical condition that might place the patient at increased risk or interfere with assessments.
16. For females: Pregnant or breastfeeding.
17. Employees of the Investigator, study centre, Sponsor, clinical research organisation and study consultants, when employees are directly involved in this study or other studies under the direction of this Investigator or study centre, and their family members.
18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
19. With an average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in at least two of the three-day self-rating diary charts for the three days preceding randomization
30 Years
ALL
No
Sponsors
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Bial - Portela C S.A.
INDUSTRY
Responsible Party
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Locations
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Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Parkinson-Klinik Ortenau GmbH&Co KG
Wolfach, Baden-Wurttemberg, Germany
Klinik Haag i. OB
Haag in Oberbayern, Bavaria, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Praxis Dr. Oehlwein
Gera, Thuringia, Germany
Asklepios Fachklinikum Stadtroda
Stadtroda, Thuringia, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Praxis Dr. med. Kirsten Hahn
Berlin, , Germany
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
Hospital Beatriz Ângelo
Loures, Lisbon District, Portugal
CNS-Campus Neurologico Senior
Torres Vedras, Lisbon District, Portugal
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Complejo Hospitalario Universitario de Orense
Ourense, , Spain
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, United Kingdom
University Hospitals Plymouth
Plymouth, Devon, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
Newcastle University- Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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Other Identifiers
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2020-002754-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIA-91067-403
Identifier Type: -
Identifier Source: org_study_id
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