A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available
- Conditions
- Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.MedDRA version: 7Level: LLTClassification code 10061536
- Registration Number
- EUCTR2006-001793-24-AT
- Lead Sponsor
- BIAL - Portela & Cª, SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Criteria for Inclusion:
At visit 1 (screening), patients must be/have:
ability to comprehend and willingness to sign an informed consent form; aged 30 to 80 years, inclusive; diagnosis of idiopathic Parkinson’s disease according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC); disease severity less than Stage 5 (modified Hoehn &Yahr staging) while during the off” time; treated with levodopa plus DDCI for at least one year with clear clinical improvement; treated with four to eight (inclusive) daily doses of standard levodopa plus DDCI (bedtime dose of a slow-release formulation is permitted); stable regimen of levodopa plus DDCI and other anti-PD drugs for at least four weeks before screening; signs of end-of-dose wearing-off” phenomenon (end-of-dose deterioration) with average total daily off time while awake of at least 1.5h excluding the early morning pre-first dose off” despite optimal anti-PD therapy, determined subjectively and objectively (observations of the investigator) for a minimum of two months before screening; ability to keep reliable diaries of motor fluctuations (alone or with family/caregiver assistance); patient must be amenorrhoeic for at least one year or surgically sterile for at least six months before screening, in case of women of childbearing potential, patient must be using a double-barrier contraceptive method.
At visit 2 (entry to Period 1), patients must be/have:
results of laboratory tests acceptable by the investigator (not clinically significant for the well-being of the patient or for the purpose of the study); At visit 3 (randomisation), patients must be/have: at least 80% treatment medication (levodopa/DDCI + investigational product) compliance with the recommended dosage regimen of single-blind placebo during Period 1; self-rating diary charts filled-in in accordance with the diary chart instructions (less than three errors per day are allowed); average of at least 1.5 off” hours per day (excluding the early morning pre-first dose off” period) on the three-day diaries, filled in at the three days preceding visit V3, according to the self-rating diary charts completed during Period 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Criteria for Exclusion:
At visit 1 (screening), patients must not be/have:
non-idiopathic PD (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome); dyskinesia disability score more than 3 in UPDRS IV.A item 33; DSM IV criterion for dementia; major depressive episode within the six months before screening; treatment with entacapone, tolcapone, neuroleptics, antidepressants [except serotonin specific reuptake inhibitors (SSRI) or imipraminics (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 the three months before screening; treatment with apomorphine within the previous month before screening; dosage change of concomitant anti-PD medication within 4 weeks of screening; any investigational product within the three months (or within five half-lives, whichever is longer) before screening; a psychiatric or any medical condition that might place the subject at increased risk or interfere with assessment; 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; pheochromocytoma; known hypersensitivity to the ingredients of products used; unstable concomitant disease being treated with changing doses of medication; history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the subject or related to the study conditions, e.g., which may influence the absorption or metabolism (e.g., hepatic impairment) of the investigational drug; any abnormality in the liver enzymes above two times the upper limit of the normal range.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary: <br>To investigate the safety and tolerability of the combined treatment (levodopa/DDCI plus nebicapone, entacapone or placebo).<br>;Primary end point(s): Primary: Change from baseline in absolute off”-time (patient’s diaries);Main Objective: Primary:<br>To investigate the effect on the wearing-off phenomenon of three different doses of nebicapone (50 mg, 100 mg and 150 mg), compared with entacapone (200 mg) and placebo when administered concomitantly with existing treatment with levodopa plus a dopa decarboxylase inhibitor (carbidopa or benserazide).<br>
- Secondary Outcome Measures
Name Time Method