Efficacy and Safety of Opicapone in Clinical Practice

NCT02847442 | Completed Phase 4

• 2 other identifiers: BIA-OPC-4012016-002391-27
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease With Wearing-off Motor Fluctuations

Keywords

Ongentys

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment of Change

  Through study completion, an average of three months

Secondary Outcomes (10)

• Change in L-dopa total daily dose

  Through study completion, an average of 3 months

• percentage of subjects with change in number of daily L-dopa doses

  Through study completion, an average of 3 months

• percentage of subjects with change in L-dopa single dose (SD)

  Through study completion, an average of 3 months

• percentage of subjects with stable L-dopa regimen

  Through study completion, an average of 3 months

• percentage of subjects for whom OPC will be prescribed

  Through study completion, an average of 3 months

Study Arms (1)

Opicapone (BIA 9-1067) 50 mg

EXPERIMENTAL

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; Drug: levodopa/dopa decarboxylase inhibitor

Interventions

BIA 9-1067 DRUG

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.

Also known as: Ongentys, Opicapone

Opicapone (BIA 9-1067) 50 mg

levodopa/dopa decarboxylase inhibitor DRUG

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

Also known as: L-dopa/DDCI

Opicapone (BIA 9-1067) 50 mg

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

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

Dresden, 01307, Germany

Location

Related Publications (2)

• Schofield C, Chaudhuri KR, Carroll C, Sharma JC, Pavese N, Evans J, Foltynie T, Reichmann H, Zurowska L, Soares-da-Silva P, Lees A. Opicapone in UK clinical practice: effectiveness, safety and cost analysis in patients with Parkinson's disease. Neurodegener Dis Manag. 2022 Apr;12(2):77-91. doi: 10.2217/nmt-2021-0057. Epub 2022 Mar 21.

  PMID: 35313124 DERIVED

• Reichmann H, Lees A, Rocha JF, Magalhaes D, Soares-da-Silva P; OPTIPARK investigators. Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020 Mar 4;9(1):9. doi: 10.1186/s40035-020-00187-1.

  PMID: 32345378 DERIVED

MeSH Terms

Interventions

opicapone

Study Design

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

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 28, 2016
• Study Start: November 23, 2016
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

DE (1)