Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Opicapone in Clinical Practice (OPTIPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02847442
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease With Wearing-off Motor Fluctuations Drug: BIA 9-1067 Drug: levodopa/dopa decarboxylase inhibitor Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations
Actual Study Start Date : November 23, 2016
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : July 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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:
  • Ongentys
  • Opicapone

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 Name: L-dopa/DDCI




Primary Outcome Measures :
  1. Investigator's Global Assessment of Change [ Time Frame: Through study completion, an average of three months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847442


Locations
Layout table for location information
Germany
University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic
Dresden, Germany, 01307
Sponsors and Collaborators
Bial - Portela C S.A.

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02847442     History of Changes
Other Study ID Numbers: BIA-OPC-401
2016-002391-27 ( EudraCT Number )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bial - Portela C S.A.:
Ongentys

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Opicapone
Dopa Decarboxylase
Aromatic Amino Acid Decarboxylase Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors