Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.
NCT ID: NCT01227655
Last Updated: 2015-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2011-03-31
2012-07-31
Brief Summary
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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.
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Detailed Description
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DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
BIA 9-1067
Capsules will be used.
Levodopa
Carbidopa
DOPA decarboxylase inhibitor (DDCI)
Benserazide
DOPA decarboxylase inhibitor
BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
BIA 9-1067
Capsules will be used.
Levodopa
Carbidopa
DOPA decarboxylase inhibitor (DDCI)
Benserazide
DOPA decarboxylase inhibitor
Placebo
PLC, Placebo
Placebo
comparator
Levodopa
Carbidopa
DOPA decarboxylase inhibitor (DDCI)
Benserazide
DOPA decarboxylase inhibitor
Interventions
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BIA 9-1067
Capsules will be used.
Placebo
comparator
Levodopa
Carbidopa
DOPA decarboxylase inhibitor (DDCI)
Benserazide
DOPA decarboxylase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
83 Years
ALL
No
Sponsors
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Bial - Portela C S.A.
INDUSTRY
Responsible Party
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Locations
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Bial - Portela & Cª, S.A.
S. Mamede Do Coronado, , Portugal
Countries
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References
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Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703.
Other Identifiers
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2010-022366-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIA-91067-302
Identifier Type: OTHER
Identifier Source: secondary_id
BIA-91067-302
Identifier Type: -
Identifier Source: org_study_id
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