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

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ClinicalTrials.gov Identifier: NCT01227655
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : January 13, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: BIA 9-1067 Drug: Placebo Drug: Levodopa Drug: Carbidopa Drug: Benserazide Phase 3

Detailed 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 427 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BIA 9-1067 25 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 25 mg once daily (QD).
 Drug: BIA 9-1067
Capsules will be used.
Other Name: Opicapone

Drug: Levodopa
Other Name: L-Dopa

Drug: Carbidopa
DOPA decarboxylase inhibitor (DDCI)

Drug: Benserazide
DOPA decarboxylase inhibitor
Experimental: BIA 9-1067 50 mg once daily (QD).
BIA 9-1067, OPC, Opicapone 50 mg once daily (QD).
 Drug: BIA 9-1067
Capsules will be used.
Other Name: Opicapone

Drug: Levodopa
Other Name: L-Dopa

Drug: Carbidopa
DOPA decarboxylase inhibitor (DDCI)

Drug: Benserazide
DOPA decarboxylase inhibitor
Placebo Comparator: Placebo
PLC, Placebo
 Drug: Placebo
comparator
Other Name: placebo; PLC

Drug: Levodopa
Other Name: L-Dopa

Drug: Carbidopa
DOPA decarboxylase inhibitor (DDCI)

Drug: Benserazide
DOPA decarboxylase inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor) [ Time Frame: 14-15 weeks ]
    Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.


Secondary Outcome Measures :
  1. UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON) [ Time Frame: 14-15 weeks ]

    Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint

    • UPDRS I evaluation of mentation, behavior, and mood
    • UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
    • UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.

    Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe

    The final cumulative score will range from 0 (no disability) to 199 (total disability).


  2. Parkinson's Disease Sleep Scale (PDSS) [ Time Frame: 14-15 weeks ]

    The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.

    Subscale has 0-10 ratings, where 0 = severe and 10 = normal

    The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability.


  3. Non-motor Symptoms Scale (NMSS) [ Time Frame: 14-15 weeks ]

    The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3

    Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4

    The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.

    The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability.



Eligibility Criteria
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Ages Eligible for Study:   30 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227655


Locations
Layout table for location information
Portugal
Bial - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01227655    
Other Study ID Numbers: BIA-91067-302
2010-022366-27 ( EudraCT Number )
BIA-91067-302 ( Other Identifier: Bial - Portela & Cª., S.A. )
First Posted: October 25, 2010    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015
Keywords provided by Bial - Portela C S.A.:
Parkinson
PD
Wearing-off
Levodopa/DDCI
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Opicapone
 Benserazide
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors