Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

October 25, 2019 updated by: Impax Laboratories, LLC

A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

  • levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
  • carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Site 1
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
  • Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

Exclusion Criteria:

  • Diagnosed with atypical parkinsonism.
  • Allergic or non-responsive to previous carbidopa-levodopa therapy.
  • Active or history of narrow-angle or wide-angle glaucoma.
  • History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
  • Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
  • Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
  • Treatment with any dopaminergic blocking agent within the previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
Drug: CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Drug: IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • CD-LD ER 200 mg
Drug: IPX054 Placebo
Placebo to match IPX054 200 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Other: CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
Drug: CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Drug: IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • CD-LD ER 200 mg
Drug: IPX054 Placebo
Placebo to match IPX054 200 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
"ON" time without disabling dyskinesias
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS analysis
Time Frame: 2 weeks
2 weeks
Mean time to "ON"
Time Frame: 2 weeks
2 weeks
Mean time to "wearing OFF"
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impax Laboratories, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPX054-B04-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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