Patients with advanced Parkinson’s disease with motor fluctuations and “OFF” periods refractory to conventional treatment. MedDRA version: 9.1 Level: LLT Classification code 10034006 Term: Parkinson's disease aggravated
Conditions
Sponsors
Axxonis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of Lisparin® applied as subcutaneous infusion compared to placebo in this indication. ;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 | — |
Countries
Austria, Czech Republic, Germany, Italy
Outcome results
None listed