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A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01568034
First received: March 29, 2012
Last updated: December 19, 2014
Last verified: December 2014
  Purpose
The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Condition Intervention Phase
Parkinson's Disease
Drug: BIA 9-1067
Drug: Placebo
Drug: Levodopa/Carbidopa
Drug: Levodopa/Benzerazide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cmax - Maximum Plasma Concentration Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Cmax - Maximum plasma concentration (ng/mL)

  • Tmax = Time to Cmax Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    tmax = time to Cmax (values are median)


Secondary Outcome Measures:
  • AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)


Enrollment: 10
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence A

Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Drug: BIA 9-1067
BIA 9-1067 - 25 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 50 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 100 mg single-dose
Other Name: OPC, Opicapone
Drug: Placebo
single-dose
Other Name: PLC
Drug: Levodopa/Carbidopa
Levodopa 100 mg Carbidopa 25 mg
Other Name: Sinemet
Drug: Levodopa/Benzerazide
Levodopa 100 mg Benzerazide 25 mg
Other Name: Madopar®/Restex®
Experimental: Treatment Sequence B

Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Drug: BIA 9-1067
BIA 9-1067 - 25 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 50 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 100 mg single-dose
Other Name: OPC, Opicapone
Drug: Placebo
single-dose
Other Name: PLC
Drug: Levodopa/Carbidopa
Levodopa 100 mg Carbidopa 25 mg
Other Name: Sinemet
Drug: Levodopa/Benzerazide
Levodopa 100 mg Benzerazide 25 mg
Other Name: Madopar®/Restex®
Experimental: Treatment Sequence C

Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Drug: BIA 9-1067
BIA 9-1067 - 25 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 50 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 100 mg single-dose
Other Name: OPC, Opicapone
Drug: Placebo
single-dose
Other Name: PLC
Drug: Levodopa/Carbidopa
Levodopa 100 mg Carbidopa 25 mg
Other Name: Sinemet
Drug: Levodopa/Benzerazide
Levodopa 100 mg Benzerazide 25 mg
Other Name: Madopar®/Restex®
Experimental: Treatment Sequence D

Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Drug: BIA 9-1067
BIA 9-1067 - 25 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 50 mg single-dose
Other Name: OPC, Opicapone
Drug: BIA 9-1067
BIA 9-1067 - 100 mg single-dose
Other Name: OPC, Opicapone
Drug: Placebo
single-dose
Other Name: PLC
Drug: Levodopa/Carbidopa
Levodopa 100 mg Carbidopa 25 mg
Other Name: Sinemet
Drug: Levodopa/Benzerazide
Levodopa 100 mg Benzerazide 25 mg
Other Name: Madopar®/Restex®

Detailed Description:
This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
  • Aged between 30 and 75 years, inclusive;
  • A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability);
  • Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy;
  • Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation;
  • Modified Hoehn and Yahr stage of less than 5 in the off-state;
  • Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical information);
  • Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to randomisation;
  • Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the subject or for the purpose of the study);
  • Able and willing to give written informed consent.

Exclusion Criteria:

  • Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
  • Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation;
  • Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to randomisation;
  • Treated with apomorphine within 7 days prior to randomisation;
  • Treated with any investigational product within 2 months prior to randomisation (or within 5 half-lives, whichever is longer);
  • A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;
  • Known hypersensitivity to any of the ingredients of the investigational products;
  • A history of abuse of alcohol, drugs or medications within the last 2 years;
  • A clinically relevant ECG abnormality;
  • A history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia;
  • Unstable concomitant disease being treated with changing doses of medication;
  • A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the subject (e.g., hepatic or renal impairment) or related to the study conditions;
  • A test positive for the human immunodeficiency viruses (HIV) 1 or 2 antibodies, or hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb);
  • Donated blood or received blood or blood products within the 6 months prior to randomisation;
  • Pregnant, breast-feeding or of childbearing potential;
  • Other condition or circumstance that, in the opinion of the investigator, may compromise the subject's ability to comply with the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568034

Locations
Portugal
Department of Neurology-Hospital de Santa Maria-Faculty of Medicine, University of Lisbon
Lisbon, Portugal, 1649-035
Romania
Spitalul Clinic Colentina - Clinica de Neurologie
Bucharest, Romania, 020125
Ukraine
Department of Neurology- Hospital of the department of medical care of Ministry Internal Affairs of Ukraine
Kyiv, Ukraine, 04050
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Joaquim Ferreira, MD, PhD Hospital de Santa Maria - Lisbon
  More Information

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01568034     History of Changes
Other Study ID Numbers: BIA-91067-201  2008-003869-72 
Study First Received: March 29, 2012
Results First Received: February 5, 2014
Last Updated: December 19, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Parkinson's Disease
BIA 9-1067

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Opicapone
Carbidopa
Aromatic Amino Acid Decarboxylase Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016