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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IPX054 200 mg
CD-LD IR
IPX054 Placebo
CD-LD IR Placebo
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

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

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.

Sites / Locations

  • Site 1
  • Site 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

IPX054 - CD-LD IR

CD-LD IR - IPX054

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

"ON" time without disabling dyskinesias

Secondary Outcome Measures

UPDRS analysis
Mean time to "ON"
Mean time to "wearing OFF"

Full Information

First Posted
November 11, 2005
Last Updated
October 25, 2019
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00253084
Brief Title
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Official Title
A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 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

Data Monitoring Committee
No

5. Study Description

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPX054 - CD-LD IR
Arm Type
Other
Arm Description
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.
Arm Title
CD-LD IR - IPX054
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IPX054 200 mg
Other Intervention Name(s)
CD-LD ER 200 mg
Intervention Description
IPX054 containing 50 mg carbidopa and 200 mg levodopa
Intervention Type
Drug
Intervention Name(s)
CD-LD IR
Intervention Description
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Intervention Type
Drug
Intervention Name(s)
IPX054 Placebo
Intervention Description
Placebo to match IPX054 200 mg
Intervention Type
Drug
Intervention Name(s)
CD-LD IR Placebo
Intervention Description
Placebo to match CD-LD IR
Primary Outcome Measure Information:
Title
"ON" time without disabling dyskinesias
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
UPDRS analysis
Time Frame
2 weeks
Title
Mean time to "ON"
Time Frame
2 weeks
Title
Mean time to "wearing OFF"
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 1
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site 2
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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