Continuous Application of Lisparin in Parkinson s Disease by Subcutaneous Infusion 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

• Conditions: Patients to be included in the study should experience wearing-off or other OFF periods and troublesome dyskinesia of at least four hours/day although they receive an individually optimised therapy with currently available oral anti-Parkinson drugs. An Off -period is defined as the time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. The term dyskinesia is used to describe involuntary, more or less fierce movements of limbs or; MedDRA version: 6.1Level: PTClassification code 10061536

• Registration Number: EUCTR2005-001006-12-IT
• Lead Sponsor: AXXONIS PHARMA GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-17
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 and with 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 anticholinergics 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
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

Exclusion Criteria

Non-idiopathic Parkinson s disease e.g. drug-induced or other forms of secondary or atypical parkinsonism such as multiple system atrophy, MSA Significant neurological symptoms not accounted for by Parkinson s disease History or presence of dementia, demonstrated by the Mini-mental status examination MMSE 24 Presence of major depression according to DSM IV criteria 8805; 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 otherwise symptomatic orthostatic hypotension Present treatment with neuroleptics, including atypical neuroleptics Treatment with other CNS active drug therapy e.g. sedatives, hypnotics, anti-depressants, anxiolytics unless the dose has been stable for at least four weeks prior to the baseline visit Participation in another trial of an investigational drug within the last 28 days or current participation in another trial of an investigational drug Clinically significant laboratory abnormalities Previous neurosurgery in Parkinson s disease Alcohol or drug abuse in the past three years Women of childbearing potential without adequate and effective form of birth control with a Pearl index 1 e.g. abstinence, hormonal contraception, hormonal IUD Pregnancy or lactation Known hypersensitivity to Lisurid, Ropinirole, Pramipexol, Cabergoline, or other ergoline substances. History of pleural effusion or fibrosis or acute pulmonary fibrosis. Raynaud-syndrome Known gastro-intestinal ulcers or bleedings Clinically significant liver failure total bilirubin 2.0 mg/dl or SGOT and/or SGPT greater than two times the upper limit of the reference range Clinically relevant renal dysfunction serum creatinine 2.0 mg/dl QTc interval 470 msec at screening ECG Co-medication with drugs prolonging the QTc interval, e.g. oral ketoconalzole or other inhibitors of the cytocrome system Other known risk factors for Torsades de Pointes arrhythmias e.g. cardiac insufficiency NYHA II-IV, hypokalemia, hereditary long-QT-syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The general objective in this study is to investigate the efficacy and safety of subcutaneously applied Lisparin given as a continuous infusion as add-on medication in levodopa-treated patients with Parkinson s diseases and motor complications with no or poor response to standard therapy.;Secondary Objective: The secondary objectives are to investigate further the effect of study treatment in an explorative manner.;Primary end point(s): Total daily OFF-time and ON-time with troublesome dyskinesia based on patient s diaries comparison between double-blind treatment with Lisparin or placebo with regard to changes from Baseline B0 to T6.