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A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

NCT00974974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2020-08-11

Study results available
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Summary

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Conditions

Interventions

DRUG

IPX066

extended-release carbidopa-levodopa capsules

DRUG

IR CD-LD

immediate-release carbidopa-levodopa tablets

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Poland
  • Romania
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974974 on ClinicalTrials.gov