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Parkinson's DiseasePhase 3NCT01568073

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

A Phase 3 study testing BIA 9-1067, Entacapone and Levodopa in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations. Read more about this study

Who is it for?
Ages 30 to 83 years
Conditions the study is for
Parkinson's Disease
What is being tested?
BIA 9-1067, Entacapone and Levodopa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
1 sitePortugal
Study dates
Mar 2011to Nov 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 83 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • V1 (Screening, up to 14 days before V2)
  • Able to comprehend and willing to sign an informed consent form.
  • Male and female subjects between 30 and 83 years old, inclusive.
  • Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
  • Disease severity Stages I-III (modified Hoehn \&Yahr staging) at ON.
  • Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement as per investigator's judgment.
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  • Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
  • On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
  • Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening, with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment).
  • Able to keep reliable diaries of motor fluctuations (alone or with family/caregiver assistance).
  • Amenorrheic for at least 1 year or surgically sterile for at least 6 months before screening. Females of childbearing potential must be using an effective non-hormonal contraceptive method.
  • V2 (Randomisation, Day 0)
  • Have filled-in self-rating diary charts in accordance with the diary chart instructions and with ≤ 3 errors per day.
  • At least 1.5 OFF hours per day, excluding 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 the self-rating diary for at least 2 of the 3 days preceding V2.
  • Results of the screening laboratory tests are considered acceptable by the investigator (i.e. not clinically relevant for the well-being of the subject or for the purpose of the study).

Who cannot join

  • V1 (Screening, up to 14 days before V2)
  • Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
  • Dyskinesia disability score > 3 in the Unified Parkinson's Disease Rating Scale (UPDRS) Sub-section IV A, item 33.
  • Severe and/or unpredictable OFF periods.
  • Treatment with prohibited medication: tolcapone, neuroleptics, venlafaxine, monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
  • Previous use of entacapone.
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  • Treatment with apomorphine, alpha-methyldopa, or reserpine within the month before screening or likely to be needed at any time during the study.
  • Dosage change of concomitant anti-PD medication within 4 weeks of screening.
  • Previous or planned (during the entire study duration, including the OL period) deep brain stimulation.
  • Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
  • Any IMP within the 3 months (or within 5 half-lives, whichever is longer) before screening.
  • Any medical condition that might place the subject at increased risk or interfere with assessments.
  • Past (within the past year) or present history of suicidal ideation or suicide attempts.
  • Current or previous (within the past year) diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalised anxiety disorder, alcohol or substance abuse excluding caffeine or nicotine, impulse control disorders (e.g. pathological gambling), dementia or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV) American Psychiatric Association, 2000 criteria, as determined by the investigator.
  • A clinically relevant electrocardiogram (ECG) abnormality (relevance should be assessed by a cardiologist if needed).
  • Current evidence of unstable cardiovascular disease, including but not limited to uncontrolled hypertension, myocardial infarction with important systolic or diastolic dysfunction, unstable angina, congestive heart failure (New York Heart Association class ≥ III), and significant cardiac arrhythmia (Mobitz II 2nd or 3rd degree AV block or any other arrhythmia causing haemodynamic repercussions as symptomatic bradycardia or syncope).
  • Prior renal transplant or current renal dialysis.
  • Pheochromocytoma, paraganglioma, or other catecholamine secretive neoplasm.
  • Known hypersensitivity to the ingredients of IMPs used.
  • History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis.
  • History of or current cancer disease, which in the investigator's opinion would exclude the subject from the study (e.g. melanoma, prostate cancer).
  • Unstable active narrow-angle or unstable wide-angle glaucoma.
  • History of or current evidence of any relevant disease in the context of this study, i.e. with respect to the safety of the subject or related to the study conditions, e.g. which may influence the absorption or metabolism (such as a relevant liver disease) of the IMP.
  • Pregnant or breastfeeding. V2 (Randomisation, Day 0)
  • Any abnormality in the liver enzymes (alanine aminotransferase and/or aspartate aminotransferase) > 2 times the upper limit of the normal range, in the screening laboratory tests results.
  • Plasma sodium < 130 mmol/L, white blood cell count < 3000 cells/mm3, or any other relevant clinical laboratory abnormality in the screening laboratory tests results that, in the investigator's opinion, may compromise the subject's safety.
  • Inadequate compliance to concomitant L-DOPA/DDCI and other anti-PD drugs during the Screening period.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Bial - Portela & Cª, S.A.

    S. Mamede Do Coronado, 4745-457

Other trials in Portugal

About this study

Official title: Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

Read the detailed description

Efficacy and safety of BIA 9-1067 in idiopathic Parkinson's disease patients with "wearing-off" phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo- and active-controlled, parallel-group, multicentre clinical study.

Being tested
BIA 9-1067, Entacapone, Placebo, Levodopa, Carbidopa
Keywords
Parkinson, PD, Wearing-off, Levodopa/DDCI
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIA 9-1067Drug

    Also called OPC, Opicapone

    5, 25 and 50 mg of BIA 9-1067 (once-daily)

  • EntacaponeDrug

    Also called Comtan®

    200 mg entacapone (concomitantly with each L-dopa/DDCI dose)

  • PlaceboDrug

    Also called PLC

    200 mg

  • LevodopaDrug

    Also called L-Dopa

  • CarbidopaDrug

    DOPA decarboxylase inhibitor

  • BenserazideDrug

    DOPA decarboxylase inhibitor

Study groups in NCT01568073
Study groupRoleWhat they receive
BIA 9-1067ExperimentalOPC, Opicapone
Receives: Drug: BIA 9-1067; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide
EntacaponeActive comparatorComtan®; Active comparator
Receives: Drug: Entacapone; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide
PlaceboPlacebo comparatorPLC, Placebo
Receives: Drug: Placebo; Drug: Levodopa; Drug: Carbidopa; Drug: Benserazide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,

    The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations

    Measured: 14 to 15 weeks

Secondary outcomes (3)

  1. Total UPDRS SCORE (I, II (ON), and III)

    Total UPDRS (Part I, II (ON) and III)

    • UPDRS I evaluation of mentation, behavior, and mood
    • UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
    • UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.

    Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe

    The final cumulative score will range from 0 (no disability) to 199 (total disability).

    Measured: 14 to 15 weeks

  2. Parkinson's Disease Sleep Scale (PDSS)

    The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.

    Subscale has 0-10 ratings, where 0 = severe and 10 = normal

    The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability.

    Measured: 14 to 15 weeks

  3. Non-motor Symptoms Scale (NMSS)

    The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3

    Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4

    The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.

    The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability.

    Measured: 14 to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01568073
Sponsor's protocol ID
BIA-91067-301
Other IDs
2010-021860-13
Status last verified
Sep 2015
First submitted
29 Mar 2012
Last updated
18 Sep 2015
Data monitoring committee
No

Publications

  • Harrison-Jones G, Green W, Bainbridge J. The Cost-Effectiveness of Opicapone Versus Entacapone as Adjuvant Therapy for Levodopa-Treated Individuals With Parkinson's Disease Experiencing End-of-Dose Motor Fluctuations. Parkinsons Dis. 2025 Sep 11;2025:8408907. doi: 10.1155/padi/8408907. eCollection 2025.

    PubMed 40979212

  • Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23.

    PubMed 26725544

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIA 9-1067, Entacapone and Levodopa in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

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 15 inclusion and 27 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo, (time frame: 14 to 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01568073, which also lists 2 linked publications.

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 18 Sep 2015.

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