Efficacy and Safety of Opicapone in Clinical Practice (OPTIPARK)

October 12, 2018 updated by: Bial - Portela C S.A.

Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations

The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, uncontrolled, single-group, multi-centre trial in Parkinson's disease (PD) patients with wearing-off motor fluctuations.

At screening/baseline (Visit 1, Day 1) all subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI). Subjects treated with L-dopa/DDCI/entacapone before trial entry will discontinue entacapone treatment at this visit. Subjects treated with L-dopa/DDCI/tolcapone before trial entry will not be eligible, as well as those previously treated with OPC. Subjects treated with dopamine agonists will be eligible.

OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose. Therefore, on Day 15 ±3 (Visit 2) the investigator will call the subject to ask for adverse events (AE, e.g. dopaminergic AEs) and if required, to reduce the L-dopa/DDCI dose. The investigator may increase or decrease the total daily L-dopa/DDCI dose according to the subject's condition throughout the trial, except at Visit 1. At the Visit 1 the L-dopa dose should not be changed.

Further visits will be performed on Day 30 ±4 (Visit 3) and on Day 90 ±4 (Visit 4). Subjects who discontinue trial participation prematurely will be asked to come to the site for an early discontinuation visit (EDV).

In addition to the scheduled visits, subjects may be asked to call or to return to the trial site, or subjects may be called by the investigator for assessment of safety data or adjustment of L-dopa/DDCI dose (unscheduled visits).

At Visit 4 (or EDV, if applicable) the investigator will arrange for the subject's subsequent PD treatment, i.e. either prescribe further OPC or switch to another treatment.

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to comprehend and willing to sign an informed consent form.
  • Male and female subjects aged 30 years or older.
  • Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
  • Disease severity Stages I-IV (modified Hoehn - Yahr staging) at ON.
  • Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone, which can include a slow-release formulation.
  • Signs of "wearing-off" phenomenon according to the 9-Symptom Wearing-off Questionnaire (WOQ-9), despite optimal anti-PD therapy (based on the investigator's judgement). The wearing-off phenomenon has to be confirmed clinically by the investigator.
  • For females: Postmenopausal for at least two years or surgically sterile for at least six months before screening.

Exclusion Criteria:

  • Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
  • Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are eligible.
  • Previous or current use of tolcapone and/or OPC.
  • Treatment with monoamine oxidase inhibitors (MAO-A and MAO-B; 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 safinamide up to 100 mg/day) within the month before screening.
  • Concomitant treatment with entacapone.
  • Use of any other investigational medicinal product (IMP), currently or within the three months (or within five half-lives of the IMP, 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) alcohol or substance abuse excluding caffeine or nicotine.
  • Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
  • Known hypersensitivity to the ingredients of IMP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
  • History of neuroleptic malignant syndrome (NMS) or non-traumatic rhabdomyolysis.
  • Severe hepatic impairment (Child-Pugh Class C).
  • For females: Breastfeeding.
  • Employees of the investigator, trial centre, sponsor, clinical research organisation and trial consultants, when employees are directly involved in the trial or other studies under the direction of this investigator or trial centre, and their family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Opicapone (BIA 9-1067) 50 mg
Total duration of trial participation and treatment: three months. All subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI)
Drug: BIA 9-1067
Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI.
Other Names:
  • Opicapone
  • Ongentys
Drug: levodopa/dopa decarboxylase inhibitor
OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose
Other Names:
  • L-dopa/DDCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator's Global Assessment of Change
Time Frame: Through study completion, an average of three months
Through study completion, an average of three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in L-dopa total daily dose
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
percentage of subjects with change in number of daily L-dopa doses
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
percentage of subjects with change in L-dopa single dose (SD)
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
percentage of subjects with stable L-dopa regimen
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
percentage of subjects for whom OPC will be prescribed
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
percentage of subjects who stopped treatment with OPC
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 3
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 4
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Absolute values in unified Parkinson's disease rating scale (UPDRS) scale
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Change from baseline to Visit 4 in UPDRS scale
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial - Portela C S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 23, 2016

Primary Completion (ACTUAL)

July 4, 2018

Study Completion (ACTUAL)

July 4, 2018

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (ESTIMATE)

July 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-OPC-401
  • 2016-002391-27 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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