Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

October 25, 2019 updated by: Impax Laboratories, LLC

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic 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)

16

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
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Quest Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University - Parkinson's Center of Oregon

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.
  • Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
  • Must experience "wearing OFF" between doses of medication.

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 seizures.
  • Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
  • Treatment with any dopaminergic blocking agent within the previous 3 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: Sequence 1
Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Names:
  • Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Other: Sequence 2
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Names:
  • Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Other: Sequence 3
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Names:
  • Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Other: Sequence 4
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Names:
  • Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Names:
  • Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alternate tapping of keys
Time Frame: single dose
single dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Timed walking
Time Frame: single dose
single dose
Tremor score
Time Frame: single dose
single dose
Dyskinesia rating scale
Time Frame: single dose
single dose

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

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria

January 18, 2006

First Posted (Estimate)

January 20, 2006

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-B05-01

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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