Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
This study has been completed.
Sponsor:
Abbott
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00660387
First received: April 15, 2008
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Parkinson's Disease |
Drug: Active levodopa carbidopa intestinal gel (LCIG) Drug: Placebo gel Drug: Active Levodopa-carbidopa (LC) oral encapsulated tablets Drug: Placebo (PBO) levodopa-carbidopa (LC) oral capsules Device: CADD-Legacy® 1400 ambulatory infusion pump |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours) at Week 12 (endpoint) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | December 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Levodopa carbidopa intestinal gel (LCIG)
|
Drug: Active levodopa carbidopa intestinal gel (LCIG)
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)
Drug: Placebo (PBO) levodopa-carbidopa (LC) oral capsules
Placebo (PBO) levodopa-carbidopa (LC) oral capsules
Device: CADD-Legacy® 1400 ambulatory infusion pump
CADD-Legacy® 1400 ambulatory infusion pump
|
|
Active Comparator: 2
Levodopa-carbidopa (LC) oral encapsulated tablets
|
Drug: Placebo 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)
Drug: Active Levodopa-carbidopa (LC) oral encapsulated tablets
should be kept within a range of 0.5-10 mg/hour (10-200 mg levodopa/hour) and is usually (40-120 mg levodopa per/hour)
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- levodopa responsive and subjects demonstrate some identifiable 'on response' established by observation by investigator
- demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated
Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
- undergone surgery for the treatment of PD
- contraindications to levodopa
- subjects with any neurological deficit that may interfere with the study assessments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660387
Locations
| United States, Alabama | |
| Site Reference ID/Investigator# 45931 | |
| Birmingham, Alabama, United States, 35222 | |
| United States, California | |
| Site Reference ID/Investigator# 45910 | |
| Fountain Valley, California, United States, 92708 | |
| Site Reference ID/Investigator# 45925 | |
| Oceanside, California, United States, 92056 | |
| United States, Florida | |
| Site Reference ID/Investigator# 45912 | |
| Port Charlotte, Florida, United States, 33890 | |
| United States, Illinois | |
| Site Reference ID/Investigator# 45935 | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kentucky | |
| Site Reference ID/Investigator# 45930 | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, New York | |
| Site Reference ID/Investigator# 45934 | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 45929 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 45908 | |
| Cincinnati, Ohio, United States, 45267 | |
| Site Reference ID/Investigator# 45922 | |
| Cleveland, Ohio, United States, 44195-0001 | |
| United States, Washington | |
| Site Reference ID/Investigator# 45915 | |
| Kirkland, Washington, United States, 98034 | |
| New Zealand | |
| Site Reference ID/Investigator# 45904 | |
| Auckland, New Zealand, 1010 | |
| Site Reference ID/Investigator# 45902 | |
| Christchurch, New Zealand, 8011 | |
| Site Reference ID/Investigator# 45905 | |
| Hamilton, New Zealand, 3204 | |
Sponsors and Collaborators
Abbott
Quintiles
Investigators
| Study Director: | Janet Benesh | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00660387 History of Changes |
| Other Study ID Numbers: | S187.3.002, 2007-003814-32 |
| Study First Received: | April 15, 2008 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Food and Drug Administration New Zealand: Ministry of Health |
Keywords provided by Abbott:
|
levodopa-carbidopa Carbidopa levodopa dyskinesia |
Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations levodopa/carbidopa suspension |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Levodopa Carbidopa, levodopa drug combination Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Dopamine Agonists Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013