Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced Parkinson's disease with motor fluctuations and "OFF" periods refractory to conventional treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axxonis Pharma AG
• Treatments: Lisuride

Criteria

Inclusion Criteria:

• 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 demonstrated by the 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