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

NCT04990284 | Completed Phase 4

• 2 other identifiers: BIA-91067-4032020-002754-24
• Study Type: interventional
• Target: 106
• Locations: 5 countries
• Sites: 25

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Adoption; Opicapone; Motor fluctuations

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

50 mg opicapone once-daily

EXPERIMENTAL

Drug: Opicapone

100 mg of L-DOPA

EXPERIMENTAL

Drug: L-DOPA/DDCI

Interventions

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).

Also known as: BIA 9-1067

50 mg opicapone once-daily

L-DOPA/DDCI DRUG

L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration

Also known as: Levodopa

100 mg of L-DOPA

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
• Male or female patients aged 30 years or older.
• 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).
• Disease severity Stages I-III (Hoehn \& Yahr staging) at ON.
• 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.
• 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.
• 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).
• Experiencing wearing-off phenomenon for at least 4 weeks but less than 2 years prior to screening.
• 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.
• 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.
• 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.
• Adequate compliance to relevant concomitant medication during the period between V1 and V2 (based on the Investigator's judgment).

You may not qualify if:

• Non-idiopathic PD (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome).
• Severe and/or unpredictable OFF periods, according to Investigator's judgment.
• 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).
• 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.
• Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
• Previous or current use of opicapone or L-DOPA/carbidopa intestinal gel infusion.
• 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.
• Past (within the past year) or present history of suicidal ideation or suicide attempts.
• Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
• Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
• Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
• History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
• History of severe hepatic impairment (Child-Pugh Class C).
• 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.
• Any medical condition that might place the patient at increased risk or interfere with assessments.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (25)

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Parkinson-Klinik Ortenau GmbH&Co KG

Wolfach, Baden-Wurttemberg, 77723, Germany

Location

Klinik Haag i. OB

Haag in Oberbayern, Bavaria, 83527, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Praxis Dr. Oehlwein

Gera, Thuringia, 07551, Germany

Location

Asklepios Fachklinikum Stadtroda

Stadtroda, Thuringia, 07646, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Praxis Dr. med. Kirsten Hahn

Berlin, 13187, Germany

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

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

Napoli, 80138, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Santa Maria di Terni

Terni, 05100, Italy

Location

Hospital Beatriz Ângelo

Loures, Lisbon District, 2674-514, Portugal

Location

CNS-Campus Neurologico Senior

Torres Vedras, Lisbon District, 2560-280, Portugal

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital de Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, 08041, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Complejo Hospitalario Universitario de Orense

Ourense, 32005, Spain

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, Devon, EX2 5DW, United Kingdom

Location

University Hospitals Plymouth

Plymouth, Devon, PL6 8DH, United Kingdom

Location

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

Location

Newcastle University- Clinical Ageing Research Unit

Newcastle upon Tyne, Tyne & Wear, NE4 5PL, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: November 29, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); ES (7); GB (4); PT (2); DE (8)