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An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

NCT01096186 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2019-11-08

Study results available
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Summary

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Conditions

Interventions

DRUG

IPX066 95 mg

23.75 - 95 mg CD-LD capsules

DRUG

IPX066 145 mg

36.25 - 145 mg CD-LD capsules

DRUG

IPX066 195 mg

48.75 - 195 mg CD-LD capsules

DRUG

IPX066 245 mg

61.25 - 245 mg CD-LD capsules

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Canada
  • Estonia
  • Germany
  • Latvia
  • Lithuania
  • 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 NCT01096186 on ClinicalTrials.gov