Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

NCT ID: NCT01568047

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

Detailed Description

Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)

Conditions

Parkinson's Disease

Keywords

Parkinson Disease; BIA 9-1067

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

PLC, Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

once-daily

Levodopa/Carbidopa

Intervention Type: DRUG

Levodopa 100 mg Carbidopa 25 mg

Levodopa/Benzerazide

Intervention Type: DRUG

Levodopa 100 mg Benzerazide 25 mg

BIA 9-1067 - 5 mg

5 mg BIA 9-1067 (OPC, Opicapone)

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

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 - 5 mg single-dose

Levodopa/Carbidopa

Intervention Type: DRUG

Levodopa 100 mg Carbidopa 25 mg

Levodopa/Benzerazide

Intervention Type: DRUG

Levodopa 100 mg Benzerazide 25 mg

BIA 9-1067 - 15 mg

15 mg BIA 9-1067 (OPC, Opicapone)

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

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 - 15 mg single-dose

Levodopa/Carbidopa

Intervention Type: DRUG

Levodopa 100 mg Carbidopa 25 mg

Levodopa/Benzerazide

Intervention Type: DRUG

Levodopa 100 mg Benzerazide 25 mg

BIA 9-1067 - 30 mg

30 mg BIA 9-1067 (OPC, Opicapone)

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

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 - 30 mg single-dose

Levodopa/Carbidopa

Intervention Type: DRUG

Levodopa 100 mg Carbidopa 25 mg

Levodopa/Benzerazide

Intervention Type: DRUG

Levodopa 100 mg Benzerazide 25 mg

Interventions

Placebo

once-daily

Intervention Type: DRUG

BIA 9-1067

BIA 9-1067 - 5 mg single-dose

Intervention Type: DRUG

BIA 9-1067

BIA 9-1067 - 15 mg single-dose

Intervention Type: DRUG

BIA 9-1067

BIA 9-1067 - 30 mg single-dose

Intervention Type: DRUG

Levodopa/Carbidopa

Levodopa 100 mg Carbidopa 25 mg

Intervention Type: DRUG

Levodopa/Benzerazide

Levodopa 100 mg Benzerazide 25 mg

Intervention Type: DRUG

Other Intervention Names

PLC; OPC, Opicapone; OPC, Opicapone; OPC, Opicapone; Sinemet; Madopar®/Restex®

Eligibility Criteria

Inclusion Criteria

At screening (admission to the baseline period):

• Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
• Age ≥ 30 years;
• 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;
• Modified Hoehn and Yahr stage of less than 5 in the "off" state; mean duration of "off" state ≥ 1.5 h during waking hours (based on historical information);
• Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the patient or for the purpose of the study);
• Able and willing to give written informed consent.

At randomisation (completion of the baseline period):

• Been treated with a stable regimen of 3 to 8 doses per day of standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) for at least 1 week prior to randomisation;
• Mean duration of "off" state ≥ 1.5 h during waking hours (average of recordings of last 3 evaluable days on patient's diary);
• Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to admission.

Exclusion Criteria

At screening (admission to the baseline period):

• Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
• 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 2 weeks prior to admission;
• Treated with any investigational product within 1 month prior to admission (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 patient (e.g., hepatic impairment) or related to the study conditions;
• A test positive for the HIV-1 or HIV-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 admission;
• Pregnant, breast-feeding or of childbearing potential;
• Other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.

At randomisation (completion of the baseline period):

• Treated with levodopa/DDCI in a 10:1 ratio or in a controlled-release formulation during the baseline period;
• Treated with apomorphine during the baseline period;
• A clinically relevant ECG abnormality.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Neurology C.M.D.T.A. NEOMED

Brasov, , Romania

Department of Neurology-Quantum Medical Center

Bucharest, , Romania

Clinica de Medicina Fizica si Recuperare Medicala-Spitalul Clinic Judetean de Urgenta Craiova

Craiova, , Romania

Ukrainian State Scientific Research Institute of Medical and Social Problems of Disability, Department of Neurology and Adjustment Conditions

Dnipropetrovsk, , Ukraine

Department No. 23 of Communal setting of medical care Kharkiv's regional clinical psychiatric hospital No. 3,

Kharkiv, , Ukraine

Department of Neuroinfections and multiple sclerosis, SI "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine

Kharkiv, , Ukraine

Department of Clinical Physiology and Pathology of Extrapyramidal Nervous System SI "Institute of Gerontology, AMS Ukraine"

Kyiv, , Ukraine

Countries

Romania; Ukraine

Other Identifiers

2009-012897-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-91067-202

Identifier Type: -

Identifier Source: org_study_id