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Completed

NCT Number: NCT01227655

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bial - Portela & Cª, S.A.

S. Mamede Do Coronado, 4745-457, Portugal

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to comprehend and willing to sign an informed consent form.
  • Male and female subjects between 30 and 83 years old, inclusive.
  • Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
  • Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON.
  • Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
  • Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
  • On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
  • 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

  • Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
  • Dyskinesia disability score >3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
  • Severe and/or unpredictable OFF periods.
  • 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.
  • Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
  • Dosage change of concomitant anti-PD medication within 4 weeks of screening.
  • Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
  • Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
  • Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
  • Any medical condition that might place the subject at increased risk or interfere with assessments.

Treatment and study plan

BIA 9-1067

Drug

Capsules will be used.

Other names: Opicapone

Placebo

Drug

comparator

Other names: placebo; PLC

levodopa

Drug

Other names: L-Dopa

Carbidopa

Drug

DOPA decarboxylase inhibitor (DDCI)

Benserazide

Drug

DOPA decarboxylase inhibitor

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bial - Portela C S.A.

Industry

Registry information

Official study 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.

Acronym: BIPARKII

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2010
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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