Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. (BIPARKII)

BIAL

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Benserazide; Drug: Placebo; Drug: BIA 9-1067; Drug: Carbidopa; Drug: Levodopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227655

2010-022366-27 (EudraCT Number)

BIA-91067-302 (Other Identifier)

Details and patient eligibility

About

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

Full description

This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Enrollment: 427 patients

Sex: All

Ages: 30 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to comprehend and willing to sign an informed consent form.
2. Male and female subjects between 30 and 83 years old, inclusive.
3. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
4. Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON.
5. Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
6. Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
7. On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
8. Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment.

Exclusion criteria

1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
2. Dyskinesia disability score >3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
3. Severe and/or unpredictable OFF periods.
4. Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
5. Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
6. Dosage change of concomitant anti-PD medication within 4 weeks of screening.
7. Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
8. Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
9. Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
10. Any medical condition that might place the subject at increased risk or interfere with assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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427 participants in 3 patient groups, including a placebo group

BIA 9-1067 25 mg once daily (QD).

Experimental group

Description:

BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).

Treatment:

Drug: Levodopa

Drug: Benserazide

Drug: BIA 9-1067

Drug: Carbidopa

BIA 9-1067 50 mg once daily (QD).

Experimental group

Description:

BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).

Treatment:

Drug: Levodopa

Drug: Benserazide

Drug: BIA 9-1067

Drug: Carbidopa

Placebo

Placebo Comparator group

Description:

PLC, Placebo

Treatment:

Drug: Levodopa

Drug: Benserazide

Drug: Placebo

Drug: Carbidopa