Rytary (levodopa/carbidopa extended-release capsule) - Amneal
levodopa/carbidopa CR - Generic mfg.
carbidopa/levodopa - Generic mfg.
Carbidopa-levodopa extended-release (CD-LD ER) alone or in combination with carbidopa-levodopa immediate release (IR) to IPX066 followed by extension safety study of IPX066 in subjects with advanced Parkinson's disease (clinicaltrials.gov) - Jul 23, 2012 - P3, N=40; Recruiting -> Active, not recruiting 
Enrollment closed Parkinson's Disease
http://www.clinicaltrials.gov/ct2/show/NCT01411137
 
Jul 23, 2012
 
This study is ongoing, but not recruiting participants.  First Received on August 4, 2011.   Last Updated on July 23, 2012   History of Changes  Sponsor:   IMPAX Laboratories, Inc.  Collaborator:   Michael J. Fox Foundation for Parkinson's Research Information provided by (Responsible Party):  IMPAX Laboratories, Inc. ClinicalTrials.gov Identifier:  NCT01411137 Purpose The purpose of this study is to find out how doses of IPX066 required to help people with Parkinson's disease compare to those required for carbidopa-levodopa sustained-release tablets (also known as Sinemet® CR). Condition   Parkinson's Disease  Intervention   Drug: IPX066 Phase  Phase 3 Study Type:  Interventional Study Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open Label Conversion Study of Carbidopa-Levodopa Extended-Release (CD-LD ER) Taken Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease Resource links provided by NLM: Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome MedlinePlus related topics: Parkinson's Disease Drug Information available for: Levodopa Carbidopa U.S. FDA Resources Further study details as provided by IMPAX Laboratories, Inc.: Primary Outcome Measures: Patient Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ] Patient reported outcome Clinical Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ] Clinician reported outcome Parkinson's Disease Questionnaire- 8 (PDQ-8) [ Time Frame: 6 months ] [ Designated as safety issue: No ] Disease severity questionnaire Estimated Enrollment: 40 Study Start Date: August 2011 Estimated Study Completion Date: September 2012 Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure) (IR6)