Parkinson's DiseasePhase 3NCT00408915
Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion
A Phase 3 study testing Continuous Subcutaneous Lisuride Infusion in people with Parkinson's Disease, run by Axxonis Pharma AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Continuous Subcutaneous Lisuride Infusion
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Continuous Subcutaneous Lisuride Infusion
- 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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Subcutaneous Lisuride InfusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axxonis Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Winkler, Professor, Principal investigator, Klinik und Poliklinik für Neurologie der Universität Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408915
- Sponsor's protocol ID
- CALIPSO
- Other IDs
- EudraCT number:, 2005-001006-12, 2005
- Status last verified
- Mar 2012
- First submitted
- 5 Dec 2006
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00408915
- Acronym / sponsor ID
- CALIPSO
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Axxonis Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- First posted
- 7 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Subcutaneous Lisuride Infusion | Drug | – |
Primary outcome
Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Winkler, Professor principal investigator
Klinik und Poliklinik für Neurologie der Universität Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous Subcutaneous Lisuride Infusion in people with Parkinson's Disease, run by Axxonis Pharma AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline B0 to T6 in total daily "OFF-time and ON-time with troublesome dyskinesia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.