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| Sponsored by: |
Solvay Pharmaceuticals |
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00335153 |
Purpose
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 6-12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations
| Condition | Intervention | Phase |
|
Advanced Parkinson's Disease |
Drug: Levodopa-Carbidopa intestinal gel Device: CADD-Legacy® 1400 |
Phase III |
| Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
| MedlinePlus related topics: | Parkinson's Disease |
| ChemIDplus related topics: | Levodopa Carbidopa |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, 6-Months Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor-Fluctuations |
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Levodopa-Carbidopa intestinal gel
should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
Device: CADD-Legacy® 1400
ambulatory infusion pump
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Eligibility
| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Staci Rokette | staci.rokette@solvay.com |
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Show 66 Study Locations |
| Solvay Pharmaceuticals |
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Solvay Pharmaceuticals ( Staci Rokette ) |
| Study ID Numbers: | S187.3.004, 2006-005186-18 |
| First Received: | June 8, 2006 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00335153 |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe; Spain: Spanish Agency of Medicines; Portugal: National Pharmacy and Medicines Institute; Italy: The Italian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Finland: National Agency for Medicines; Czech Republic: State Institute for Drug Control; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency; Russia: Ministry of Health and Social Development of the Russian Federation |
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