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 with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.MedDRA version: 9.1Level: LLTClassification code 10034006Term: Parkinson's disease aggravated
- Registration Number
- EUCTR2005-001006-12-DE
- Lead Sponsor
- Axxonis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
•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
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
•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
•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 for 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
•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 Secondary Objective: To evaluate long-term efficacy, local tolerability and safety of Lisparin® applied as subcutaneous infusion compared to placebo. ;Primary end point(s): Change from baseline B0 to T6 in total daily OFF-time and ON-time with troublesome dyskinesia”, based upon patient diaries<br><br>;Main Objective: To confirm superiority of Lisparin® applied as subcutaneous infusion compared to placebo in this indication.<br>
- Secondary Outcome Measures
Name Time Method