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A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

NCT00880620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2019-10-29

Study results available
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Summary

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Conditions

Interventions

DRUG

Placebo

Placebo

DRUG

IPX066 95 mg LD

IPX066 capsule containing 95 mg LD/23.75 mg CD

DRUG

IPX066 145 mg LD

IPX066 capsule containing 145 mg LD/36.25 mg CD

DRUG

IPX066 195 mg LD

IPX066 capsule containing 195 mg LD/48.75 mg CD

DRUG

IPX066 245 mg LD

IPX066 capsule containing 245 mg LD/61.25 mg CD

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
2009-04-30
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • United States
  • Canada
  • Estonia
  • Latvia
  • Lithuania
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT00880620 on ClinicalTrials.gov