Parkinson's Disease With Wearing-off Motor Fluctuations Clinical Trial
— OPTIPARKOfficial title:
Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations
| Verified date | October 2018 |
| Source | Bial - Portela C S.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 518 |
| Est. completion date | July 4, 2018 |
| Est. primary completion date | July 4, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic | Dresden |
| Lead Sponsor | Collaborator |
|---|---|
| Bial - Portela C S.A. |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator's Global Assessment of Change | Through study completion, an average of three months | ||
| Secondary | Change in L-dopa total daily dose | Through study completion, an average of 3 months | ||
| Secondary | percentage of subjects with change in number of daily L-dopa doses | Through study completion, an average of 3 months | ||
| Secondary | percentage of subjects with change in L-dopa single dose (SD) | Through study completion, an average of 3 months | ||
| Secondary | percentage of subjects with stable L-dopa regimen | Through study completion, an average of 3 months | ||
| Secondary | percentage of subjects for whom OPC will be prescribed | Through study completion, an average of 3 months | ||
| Secondary | percentage of subjects who stopped treatment with OPC | Through study completion, an average of 3 months | ||
| Secondary | Subject's Global Assessment of Change at Visit 3 | Through study completion, an average of 3 months | ||
| Secondary | Subject's Global Assessment of Change at Visit 4 | Through study completion, an average of 3 months | ||
| Secondary | Absolute values in unified Parkinson's disease rating scale (UPDRS) scale | Through study completion, an average of 3 months | ||
| Secondary | Change from baseline to Visit 4 in UPDRS scale | Through study completion, an average of 3 months |