Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408915
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2006-12-05
Brief Title:
Continuous Application of Lisuride in Parkinsons Disease by Subcutaneous Infusion
Sponsor:
Axxonis Pharma AG
Organization:
Axxonis Pharma AG
Study Overview
Official Title:
Double-blind Placebo-controlled Randomized Multicentre Phase IIIII Study to Evaluate the Efficacy and Safety of Lisuride Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinsons Disease Refractory to Conventional Oral Therapy
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 andor 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 capsuleblinded 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
The controlled core study is scheduled to last six weeks Within the study the previous oral therapy will either be continued in a capsuleblinded 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-001006-12 | None | None | None |
| EudraCT number | None | None | None |