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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01227655
First received: October 22, 2010
Last updated: February 18, 2013
Last verified: June 2012
History of Changes
  Purpose

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/carbidopa or L-DOPA/benserazide preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.


Condition Intervention Phase
Parkinson's Disease
 Drug: BIA 9-1067
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • To investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg),administered once a day, compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations. [ Time Frame: 14-15 weeks ] [ Designated as safety issue: No ]
    The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.


Secondary Outcome Measures:
  • UPDRS Sections I (ON), II (ON and OFF), and III (ON) [ Time Frame: 14-15 weeks ] [ Designated as safety issue: No ]
  • Parkinson's Disease Sleep Scale (PDSS) [ Time Frame: 14-15 weeks ] [ Designated as safety issue: No ]
  • Non-motor Symptoms Scale (NMSS) [ Time Frame: 14-15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 405
Study Start Date: March 2011
Estimated Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIA 9-1067 25 mg once daily (QD). Drug: BIA 9-1067
Capsules will be used.
Other Name: Opicapone
Experimental: BIA 9-1067 50 mg once daily (QD). Drug: BIA 9-1067
Capsules will be used.
Other Name: Opicapone
Placebo Comparator: Placebo Drug: Placebo
comparator
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   30 Years to 83 Years
Genders Eligible for Study:   Both
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 (UKPDSBBCDC) 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 (IMP) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227655

Locations
Portugal
Bial - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01227655     History of Changes
Other Study ID Numbers: BIA-91067-302, 2010-022366-27, BIA-91067-302
Study First Received: October 22, 2010
Last Updated: February 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Australia: National Health and Medical Research Council
India: Central Drugs Standard Control Organization
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bial - Portela C S.A.:
Parkinson
PD
Wearing-off
Levodopa/DDCI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 23, 2013