Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
This study is ongoing, but not recruiting participants.
Sponsor:
Abbott
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00360568
First received: August 3, 2006
Last updated: September 12, 2012
Last verified: September 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2006 | ||||
| Last Updated Date | September 12, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Long-term safety of LCIG over a 12-month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety data during long-term treatment | ||||
| Change History | Complete list of historical versions of study NCT00360568 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mean daily 'off' time (hours), UPDRS, CGI-I, PDQ 39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Change from baseline in mean daily “off” time (hours), based on the three consecutive day average “off” time for the diary at endpoint. | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects | ||||
| Official Title ICMJE | Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | ||||
| Brief Summary | Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: 1
Levodopa-carbidopa intestinal gel
Interventions:
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria - Patients with medically relevant abnormal findings (labs, ECG, physical examination, AEs, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (week 12) of study S187.3.001 or S187.3.002 |
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Germany, New Zealand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00360568 | ||||
| Other Study ID Numbers ICMJE | S187.3.003, 2006-000578-53 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Abbott | ||||
| Study Sponsor ICMJE | Abbott | ||||
| Collaborators ICMJE | Quintiles | ||||
| Investigators ICMJE |
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| Information Provided By | Abbott | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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