Efficacy and Safety of Opicapone in Clinical Practice

• Status: Completed
• Trial end date: 2018-07-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Aromatic Amino Acid Decarboxylase Inhibitors; Dopa Decarboxylase; Levodopa; Opicapone

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.