Opicapone (OPC) is a third generation catechol O methyltransferase (COMT) inhibitor (COMTi) developed by BIAL-Portela \& Cª, S.A. It is approved as adjunctive therapy to preparations of L-DOPA/DDCI in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. Carbidopa and benserazide are both DDCIs used in association with L DOPA. When OPC is co administered with L DOPA/DDCI, peripheral COMT is inhibited and thus L DOPA plasma levels increase, increasing L DOPA bioavailability. The purpose of this Phase III study is to explore the potential of OPC to enhance the clinical benefit of L-DOPA in L DOPA treated patients in the early stages of Parkinson's Disease (PD) (patients without end-of-dose motor fluctuations, 'non fluctuators').
This is a Phase III study to evaluate the efficacy and safety of OPC in subjects with early idiopathic PD receiving treatment with L DOPA plus a DDCI, and who are without signs of any motor complication (consisting of fluctuations in the motor response and/or involuntary movements or dyskinesias). After a screening period of up to 4 weeks, eligible subjects will be randomized into 1 of 2 treatment arms (OPC 50 mg, or placebo) in a 1:1 ratio, and enter a 24-week placebo-controlled, parallel-group, double blind period. At the end of the double-blind period, subjects may enter an additional 1-year, open-label period, at the discretion of both the Investigator and subject, in which all subjects will be treated with OPC 50 mg. A Post-study Visit (PSV) will be performed approximately 2 weeks after the End of Study Visit (EOS) or Early Discontinuation Visit (EDV). Study treatment will be administered in combination with existing treatment of L-DOPA/DDCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
410
Capsule, 50 mg, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI
Capsule of to matching placebo, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI
Medical Centre "Asklepii", OOD
Dupnitsa, Bulgaria
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
Double-Blind Period. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III questionnaire will be collected at visits 2, 3, 4, 6 and 9. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assesses the motor signs of PD and is rated by the investigator (score range 0-132). Part III contains 33 scores based on 18 items. A higher score indicates more severe symptoms of PD.
Time frame: Up to 24 weeks
Change from open-label baseline (Visit 9) to the end of the open-label period (Visit 15) in MDS-UPDRS Part IV total score.
Open-Label Period. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV questionnaire will be collected at Visits 9, 10, 11, 12, 13, 14 and 15. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part IV assesses the motor complications of PD, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation; score range 0-24) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. A higher score indicates more severe symptoms of PD.
Time frame: Up to 1-year.
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