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

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IPX054 200 mg
IPX054 250 mg
CD-LD IR
CD-LD CR
IPX054 200 mg Placebo
IPX054 250 mg Placebo
CD-LD IR Placebo
CD-LD CR Placebo
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic 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. 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.

Sites / Locations

  • Quest Research Institute
  • Oregon Health Sciences University - Parkinson's Center of Oregon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Alternate tapping of keys

Secondary Outcome Measures

Timed walking
Tremor score
Dyskinesia rating scale

Full Information

First Posted
January 18, 2006
Last Updated
October 25, 2019
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00279825
Brief Title
Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (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 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.
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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Other
Arm Description
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.
Arm Title
Sequence 2
Arm Type
Other
Arm Description
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.
Arm Title
Sequence 3
Arm Type
Other
Arm Description
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.
Arm Title
Sequence 4
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IPX054 200 mg
Intervention Description
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Intervention Type
Drug
Intervention Name(s)
IPX054 250 mg
Intervention Description
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Intervention Type
Drug
Intervention Name(s)
CD-LD IR
Other Intervention Name(s)
Carbidopa-levodopa immediate-release tablets
Intervention Description
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Intervention Type
Drug
Intervention Name(s)
CD-LD CR
Other Intervention Name(s)
Carbidopa-levodopa controlled-release tablets
Intervention Description
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Intervention Type
Drug
Intervention Name(s)
IPX054 200 mg Placebo
Intervention Description
Placebo to match IPX054 200 mg
Intervention Type
Drug
Intervention Name(s)
IPX054 250 mg Placebo
Intervention Description
Placebo to match IPX054 250 mg
Intervention Type
Drug
Intervention Name(s)
CD-LD IR Placebo
Intervention Description
Placebo to match CD-LD IR
Intervention Type
Drug
Intervention Name(s)
CD-LD CR Placebo
Intervention Description
Placebo to match CD-LD CR
Primary Outcome Measure Information:
Title
Alternate tapping of keys
Time Frame
single dose
Secondary Outcome Measure Information:
Title
Timed walking
Time Frame
single dose
Title
Tremor score
Time Frame
single dose
Title
Dyskinesia rating scale
Time Frame
single dose

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. 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.
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
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Oregon Health Sciences University - Parkinson's Center of Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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