Levodopa-carbidopa Intestinal Gel Open-label Study in Advanced PD
Tracking Information
Start Date ICMJE | February 2008 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 20, 2007) | Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: June 8, 2006) | (Serious) Adverse Experiences |
Change History | Complete list of historical versions of study NCT00335153 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 20, 2007) | 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 (submitted: June 8, 2006) | Motor fluctuations measured with Patient Diary |
Descriptive Information
Brief Title ICMJE | Levodopa-carbidopa Intestinal Gel Open-label Study in Advanced PD |
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Official Title ICMJE | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor-Fluctuations |
Brief Summary | The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Advanced Parkinson's Disease |
Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 250 | ||||
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Estimated Completion Date | March 2011 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 30 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Czech Republic, Finland, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00335153 | ||||
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Responsible Party | Stephani Wilford, Solvay Pharmaceuticals | ||||
Study ID Numbers ICMJE | S187.3.004, 2006-005186-18 | ||||
Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Solvay Pharmaceuticals |
Source: http://clinicaltrials.gov/