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 MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous
Conditions
Interventions
Trade Name: Ongentys
Product Name: Ongentys
Pharmaceutical Form: Capsule, hard
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; Secondary Objective: • To show that opicapone is safe when given according to local practise. • To show that opicapone is effective at treating Parkinson's disease (PD) when given according to local practise. • To show that opicapone is cost effective in the treatment of PD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: - Change in L-dopa total daily dose from baseline (Visit 1) to each on-site visit. - Number and percentage of subjects with change in number of daily Ldopa doses from baseline (Visit 1) at each on-site visit. - Number and percentage of subjects with change in L-dopa single dose (SD) from baseline (Visit 1) at each on-site visit. - Number and percentage of subjects with stable L-dopa regimen between Visit 3 and Visit 4. - Number and percentage of subjects for whom OPC will be prescribed further after trial completion. - Number and percentage of subjects who stopped treatment with OPC before trial completion or at Visit 4 due to: - AEs - Lack of efficacy - Other reasons - Investigator's Global Assessment of Change at Visit 3. - Subject's Global Assessment of Change at Visit 3 and Visit 4. - Absolute values and, if applicable, change from baseline at each on-site visit in WOQ-9. - Absolute values and, if applicable, change from baseline to Visit 4: - UPDRS I mentation, behaviour, and mood at ON stage - UPDRS II (activities of daily living, ADL) at OFF stage - UPDRS II (ADL) plus III (motor function) during the ON stage - UPDRS IV at ON stage - PDQ-8 - NMSS Secondary safety endpoints: - Incidence of AEs including SAEs. - General safety information (vital signs, physical and neurological examinations). - BIA 9-1103, BIA 9-4588 and potential other relevant OPC metabolites’ plasma concentration at Visit 5, after 6-month treatment with OPC. ;Timepoint(s | — |
Countries
Germany, United Kingdom
Contacts
Public ContactGlobal Medical Affairs Manager
BIAL - Portela & Ca, S.A.
Outcome results
None listed