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Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Primary Purpose

Idiopathic Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

IPX054 100 mg

IPX054 150 mg

IPX054 200 mg

IPX054 250 mg

IPX054 300 mg

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring IPX054, Parkinson disease, Levodopa

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months. Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day. Exclusion Criteria: Diagnosed with atypical parkinsonism Prior surgical interventions for Parkinson's disease Glaucoma Undiagnosed skin lesion or history of melanoma Epilepsy or history of seizures

Sites / Locations

Site 101
Site 102

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: carbidopa and levodopa

Arm Description

Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.

Outcomes

Primary Outcome Measures

Parkinsonian disability at Visits 1 and 5

Secondary Outcome Measures

Full Information

NCT ID

NCT00239564

First Posted

October 13, 2005

Last Updated

October 25, 2019

Sponsor

Impax Laboratories, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00239564

Brief Title

Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Official Title

An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Impax Laboratories, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson's Disease

Keywords

IPX054, Parkinson disease, Levodopa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: carbidopa and levodopa

Arm Type

Experimental

Arm Description

Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.

Intervention Type

Drug

Intervention Name(s)

IPX054 100 mg

Other Intervention Name(s)

CD-LD ER 100 mg

Intervention Description

IPX054 containing 25 mg carbidopa and 100 mg levodopa

Intervention Type

Drug

Intervention Name(s)

IPX054 150 mg

Other Intervention Name(s)

CD-LD ER 150 mg

Intervention Description

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

Intervention Type

Drug

Intervention Name(s)

IPX054 200 mg

Other Intervention Name(s)

CD-LD ER 200 mg

Intervention Description

CD-LD CR containing 50 mg carbidopa and 200 mg levodopa

Intervention Type

Drug

Intervention Name(s)

IPX054 250 mg

Other Intervention Name(s)

CD-LD ER 250 mg

Intervention Description

CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa

Intervention Type

Drug

Intervention Name(s)

IPX054 300 mg

Other Intervention Name(s)

CD-LD ER 300 mg

Intervention Description

CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Primary Outcome Measure Information:

Title

Parkinsonian disability at Visits 1 and 5

Time Frame

36 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Impax Study Director

Organizational Affiliation

Impax Laboratories, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Site 101

City

Sunnyvale

State/Province

California

ZIP/Postal Code

94089

Country

United States

Facility Name

Site 102

City

Lawrence

State/Province

Kansas

ZIP/Postal Code

66045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

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