EUCTR2005-001006-12-CZ
Active, not recruiting
Phase 1
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO
Axxonis Pharma GmbH0 sites60 target enrollmentAugust 24, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
- Sponsor
- Axxonis Pharma GmbH
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female patients
- •Age 18 \- 75 years
- •Idiopathic Parkinson’s disease for at least 3 years (diagnosis based on the UK Brain Bank Criteria)
- •Presence of motor fluctuations (wearing\-off or other OFF periods) and / or presence of troublesome dyskinesia, with a total daily minimum of at least 4 hours, despite optimized oral anti\-parkinsonian therapy
- •Stable levodopa intake, i.e. at least four doses of levodopa per day
- •Stable dosing of all other anti\-parkinsonian drugs, such as dopamine agonists, COMT\- and MAO\-B inhibitors, amantadine, or anticholin\-ergics for a minimum of four weeks prior to inclusion.
- •The following oral dopamine agonist drugs are allowed in this trial: pramipexol up to a total daily dose of 3,15mg, ropinirol up to a total daily dose of 24mg, cabergoline up to a total daily dose of 6mg or combinations
- •Concomitant diseases are stable and well controlled
- •Willingness and ability to comply with all trial requirements
- •Written informed consent
Exclusion Criteria
- •Non\-idiopathic Parkinson’s disease (e.g. drug\-induced or other forms of secondary or atypical parkinsonism such as MSA)
- •Significant neurological symptoms not accounted for by Parkinson’s disease
- •History or presence of dementia according to clinical impressions
- •Mini\-mental status examination (MMSE \< 24\)
- •Presence of major depression according to DSM IV criteria (\= 6 months)
- •History or presence of epilepsy
- •Presence of dopaminergic psychosis
- •Unstable severe concomitant diseases (e.g. liver diseases, kidney diseases or clinically relevant cardiac or coronary dysfunction)
- •Presence of heart valvular fibrosis or indication of significant valvular stenosis / insufficiency on echocardiogram
- •History of syncope and/or severe or otherwise symptomatic orthostatic hypotension
Outcomes
Primary Outcomes
Not specified
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