Opicapone in clinical practice (OPTIPARK)

Phase 1

• Conditions: Parkinson's disease (PD) patients with wearing-off motor fluctuations; MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002391-27-GB
• Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Last Update Posted: 28 February 2019
• Study Completion: 2019-07-10

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 506

Inclusion Criteria

1. Able to comprehend and willing to sign an informed consent form.
2. Male and female subjects aged 30 years or older.
3. Diagnosed with idiopathic PD according to the UK Parkinson’s Disease Society
Brain Bank Clinical Diagnostic Criteria.
4. Disease severity Stages I-IV (modified Hoehn &Yahr staging) at ON.
5. Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone,
which can include a slow-release formulation.
6. 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.
7. For females: Postmenopausal for at least two years or surgically sterile for at
least six months before screening.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic]
parkinsonism, Parkinson-plus syndrome).
2. Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are
eligible.
3. Previous or current use of tolcapone and/or OPC.
4. 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.
5. Concomitant treatment with entacapone.
6. 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.
7. Any medical condition that might place the subject at increased risk or interfere
with assessments.
8. Past (within the past year) or present history of suicidal ideation or suicide
attempts.
9. Current or previous (within the past year) alcohol or substance abuse excluding
caffeine or nicotine.
10. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
11. Known hypersensitivity to the ingredients of IMP (including lactose intolerance,
galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption).
12. History of neuroleptic malignant syndrome (NMS) or non-traumatic rhabdomyolysis.
13. Severe hepatic impairment (Child-Pugh Class C).
14. For females: Breastfeeding.
15. 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary endpoint for this trial is the Investigator's Global Assessment of Change at Visit 4.;Timepoint(s) of evaluation of this end point: Visit 4;Main Objective: To evaluate the change in the participant's Parkinson's disease according to the Investigator’s Global Assessment of Change after six months of treatment with opicapone;<br> Secondary Objective: • To show that opicapone is safe when given according to local practise.<br> • To show that opicapone is effective at treating Parkinson's disease (PD) when given<br> according to local practise.<br> • To show that opicapone is cost effective in the treatment of PD<br>