Early Idiopathic Parkinson’s disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Ongentys
Product Name: Opicapone
Product Code: BIA 9-1067
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OPICAPONE
Current Sponsor code: BIA 9-1067
Concentration unit: mg milligra
Sponsors
BIAL – Portela & Cª, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must be 30 to 80 years of age, inclusive, at the time of signing the ICF. 2.Diagnosed with idiopathic PD according to the UK PD Society Brain Bank or MDS clinical diagnostic criteria within the previous 5 years. 3.Disease severity Stages 1 to 2.5 (according to the modified Hoehn & Yahr staging) 4.An MDS-UPDRS Part III score of =20 5.Receiving treatment with L-DOPA/DDCI for at least 1 year, and at a stable regimen for at least 4 weeks prior to Visit 2 6.Naive to COMT inhibitors (including OPC). (refer to protocol for exhaustive list of inclusion criteria) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
Exclusion criteria: 1.Non-idiopathic PD (for example, atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome). 2.Signs of motor complications with a total score of MDS-UPDRS Part IV A+B+C greater than ‘0’ (zero) 3.Treatment with prohibited medication: COMT inhibitors (eg, entacapone, tolcapone), antiemetics with antidopaminergic action (except domperidone) or Duopa™ (carbidopa/levodopa intestinal gel) within the 4 weeks before screening. 4.Concomitant use of monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of PD. 5.Previous or planned (during the entire study duration) deep brain stimulation. 6.Previous stereotactic surgery (eg, pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period. 7.Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening. 8.Any medical condition that might place the subject at increased risk or interfere with study assessments. 9.Past (within the past year) or present history of suicidal ideation or suicide attempts, as determined by a positive response (‘Yes’) to either Question 4 or Question 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) (Screening questions) (refer to protocol for exhaustive list of exclusion criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of once-daily 50 mg opicapone as add-on to stable L DOPA/DDCI therapy in patients with early-stage Parkinson’s disease.;Secondary Objective: To evaluate the safety and tolerability of once-daily 50 mg opicapone as add-on to stable L DOPA/DDCI therapy in patients with early-stage Parkinson’s disease.;Primary end point(s): Double Blind: Change from baseline (Visit 2) to the end of the double-blind period (Visit 9) in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III total score. Open Label: Change from open-label baseline (Visit 9) to the end of the open-label period (Visit 15) in MDS-UPDRS Part IV total score.;Timepoint(s) of evaluation of this end point: Visit 2, Visit 9, Visit 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Double Blind: 1. Change from baseline (Visit 2) to post-baseline visits during the double blind period in the scores of: MDS-UPDRS, Modified Hoehn & Yahr staging, Schwab and England scale, Parkinson’s Disease Sleep Scale 2 (PDSS-2), Non-Motor Symptoms Scale (NMSS), Parkinson’s Disease Questionnaire (PDQ-39) and 9-item Wearing-off questionnaire (WOQ 9). 2. Proportion of subjects with an improvement relative to their condition before the beginning of treatment in Clinical Global Impression of Improvement (CGI-I) and Patient’s Global Impression of Improvement (PGI-I) total score at post double-blind baseline visits during the double-blind period. 3. Proportion of subjects with an improvement relative to their condition at admission to the study in Patient’s Global Impression of Improvement (PGI-I) total score at post double blind baseline visits during the double-blind period Open Label: 1. Change from double-blind baseline (Visit 2) and open-label baseline (Visit 9) to post-baseline visits in the scores of: MDS-UPDRS, Modified Hoehn & Yahr staging, Schwab and England scale, PDSS-2, NMSS, PDQ-39 and WOQ-9. 2. Proportion of subjects with an improvement relative to their condition before the beginning of treatment in CGI-I and PGI-I total scores at open-label visits during the open-label period. 3.Proportion of subjects with an improvement relative to their condition at admission to the study in PGI-I total score at open-label visits during the open-label period ;Timepoint(s) of evaluation of this end point: Visit 2, Visit 9, Visit 15 | — |
Countries
Belgium, Bulgaria, Czechia, Czech Republic, France, Germany, Italy, Poland, Portugal, Serbia, Spain, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Research Physician
BIAL – Portela & Cª, S.A.
Outcome results
None listed