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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 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 Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease |
| Enrollment: | 471 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IPX066
IPX066
|
Drug: IPX066
IPX066
|
|
Active Comparator: regular Carbidopa-Levodopa
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 73 Study Locations| Study Director: | Impax Study Director | Impax Pharmaceuticals, a division of Impx Laboratories. |
More Information
| Responsible Party: | Jeff Mulchahey, PhD/Sr. Director Regualtory Affairs, IMPAX Laboratories |
| ClinicalTrials.gov Identifier: | NCT00974974 History of Changes |
| Other Study ID Numbers: | IPX066-B09-02 |
| Study First Received: | September 10, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's Disease |
|
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 |