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
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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)
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