Parkinson DiseasePhase 4ADOPTIONNCT04990284
eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.
A Phase 4 study testing Opicapone and L-DOPA/DDCI in people with Parkinson Disease, run by Bial - Portela C S.A. at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone and L-DOPA/DDCI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 29 Nov 2021to 4 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- For females: Pregnant or breastfeeding.
- 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.
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- 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
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
Germany8 sites
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12203
Praxis Dr. med. Kirsten Hahn
Berlin, 13187
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Praxis Dr. Oehlwein
Gera, Thuringia, 07551
Klinik Haag i. OB
Haag in Oberbayern, Bavaria, 83527
Asklepios Fachklinikum Stadtroda
Stadtroda, Thuringia, 07646
Parkinson-Klinik Ortenau GmbH&Co KG
Wolfach, Baden-Wurttemberg, 77723
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080
Spain7 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Ruber Internacional
Madrid, 28034
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Complejo Hospitalario Universitario de Orense
Ourense, 32005
Hospital de Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, 08041
Italy4 sites
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80138
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100
United Kingdom4 sites
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, EX2 5DW
King's College Hospital
London, Greater London, SE5 9RS
Newcastle University- Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne & Wear, NE4 5PL
University Hospitals Plymouth
Plymouth, Devon, PL6 8DH
Portugal2 sites
Hospital Beatriz Ângelo
Loures, Lisbon District, 2674-514
CNS-Campus Neurologico Senior
Torres Vedras, Lisbon District, 2560-280
About this study
Official title: A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.
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.
Read the detailed description
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
- Conditions
- Parkinson Disease
- Being tested
- Opicapone, L-DOPA/DDCI
- Keywords
- Adoption, Opicapone, Motor fluctuations
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpicaponeDrug
Also called BIA 9-1067
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/DDCIDrug
Also called Levodopa
L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration
| Study group | Role | What they receive |
|---|---|---|
| 50 mg opicapone once-daily | Experimental | Not described Receives: Drug: Opicapone |
| 100 mg of L-DOPA | Experimental | Not described Receives: Drug: L-DOPA/DDCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start29 Nov 2021
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990284
- Sponsor's protocol ID
- BIA-91067-403
- Other IDs
- 2020-002754-24
- Acronym
- ADOPTION
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT04990284
- Acronym / sponsor ID
- ADOPTION / BIA-91067-403
- Conditions
- Parkinson Disease
- Keywords
- Adoption, Opicapone, Motor fluctuations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mg opicapone once-daily | Experimental | Drug: Opicapone |
| 100 mg of L-DOPA | Experimental | Drug: L-DOPA/DDCI |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpicaponeAlso: BIA 9-106750 mg hard capsules. Oral administration, once-daily at bedtime, at least 1 hour before or after L-DOPA/carbidopa or benserazide (L-DOPA/DDCI). | Drug | 50 mg opicapone once-daily |
| L-DOPA/DDCIAlso: LevodopaL-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration | Drug | 100 mg of L-DOPA |
Primary outcome
Change in Absolute OFF-time from baseline to end of study
Time frame: up to 7 weeks
OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Proportion of patients with one hour or more reduction in Absolute OFF-time from baseline to end of study (OFF-time responders)
Time frame: up to 7 weeks
OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Change in Absolute ON-time from baseline to end of study
Time frame: up to 7 weeks
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Proportion of patients with one hour or more increase in Absolute ON-time from baseline to end of study (ON-time responders)
Time frame: up to 7 weeks
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Change in Percentage OFF-time between baseline and end of study
Time frame: up to 7 weeks
OFF = Time when medication has worn off and is no longer providing benefit with regard
Change in Percentage ON-time between baseline and end of study
Time frame: up to 7 weeks
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opicapone and L-DOPA/DDCI in people with Parkinson Disease, run by Bial - Portela C S.A. at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Spain, Italy, United Kingdom, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Absolute OFF-time from baseline to end of study (time frame: up to 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.