search
Back to results

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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Continuous Subcutaneous Lisuride Infusion
Sponsored by
Axxonis Pharma AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Lisuride, Continuous Dopaminergic Stimulation, Motor Fluctuations, Off-Times, Troublesome Dyskinesia, Parkinson's Disease with motor fluctuations with OFF periods and/or troublesome dyskinesias of more than four hours per day

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imerem GmbH

Outcomes

Primary Outcome Measures

Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia

Secondary Outcome Measures

Secondary objectives are to evaluate quality of life, quality of sleep, UPDRS Score
clinical global impression, safety and tolerability.
After the double-blind period, long-term efficacy of lisuride will be assessed for further 2 years in an open-label extension of the study

Full Information

First Posted
December 5, 2006
Last Updated
March 6, 2012
Sponsor
Axxonis Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00408915
Brief Title
Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion
Official Title
Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Axxonis Pharma AG

4. Oversight

5. Study Description

Brief 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.
Detailed Description
The current CALIPSO study investigates the efficacy of a continuous lisuride infusion against the optimized previous oral therapy in patients experiencing motor fluctuations with OFF periods and/or strenuous dyskinesias of more than four hours per day. The controlled core study is scheduled to last six weeks. Within the study the previous oral therapy will either be continued in a capsule/blinded design (while a placebo infusion is going on concurrently) or the oral therapy is substituted by lisuride infusion (while placebo capsules are administered at the same time). After the controlled core study all patients whose condition has not worsened during the study (meaning those patients of the placebo infusion group as well, who were treated during the core study just as they were before), will be given the chance to continue with the infusion therapy with lisuride in an open extension phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Lisuride, Continuous Dopaminergic Stimulation, Motor Fluctuations, Off-Times, Troublesome Dyskinesia, Parkinson's Disease with motor fluctuations with OFF periods and/or troublesome dyskinesias of more than four hours per day

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Continuous Subcutaneous Lisuride Infusion
Primary Outcome Measure Information:
Title
Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia
Secondary Outcome Measure Information:
Title
Secondary objectives are to evaluate quality of life, quality of sleep, UPDRS Score
Title
clinical global impression, safety and tolerability.
Title
After the double-blind period, long-term efficacy of lisuride will be assessed for further 2 years in an open-label extension of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Winkler, Professor
Organizational Affiliation
Klinik und Poliklinik für Neurologie der Universität Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imerem GmbH
City
Nuremberg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs