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| Sponsor: | IMPAX Laboratories, Inc. |
|---|---|
| Information provided by: | IMPAX Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00974974 |
Purpose
This is a study to evaluate the safety and efficacy of IPX066 in Advanced Parkinson's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: IPX066 Drug: regular carbidopa-levodopa |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease |
| Estimated Enrollment: | 420 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
IPX066: Experimental
IPX066
|
Drug: IPX066
IPX066
|
|
regular Carbidopa-Levodopa: Active Comparator
regular Carbidopa-Levodopa
|
Drug: regular carbidopa-levodopa
regular carbidopa-levodopa
|
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week Dose-Adjustment period for regular CD-LD, followed by a 6-week Dose-Conversion period to IPX066.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
Exclusion Criteria:
Contacts and Locations
Show 32 Study Locations
More Information
| Responsible Party: | IMPAX Laboratories ( Jeff Mulchahey, PhD/Sr. Director Regualtory Affairs ) |
| Study ID Numbers: | IPX066-B09-02 |
| Study First Received: | September 10, 2009 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00974974 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's Disease |
|
Neurotransmitter Agents Levodopa Immunologic Factors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Carbidopa Adjuvants, Immunologic Central Nervous System Diseases Antiparkinson Agents |
Enzyme Inhibitors Dopamine Agonists Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Sinemet Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |