NCT00239564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 29, 2019

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

October 13, 2005

Last Update Submit

October 25, 2019

Conditions

Idiopathic Parkinson's Disease

Keywords

IPX054Parkinson diseaseLevodopa

Outcome Measures

Primary Outcomes (1)

  • Parkinsonian disability at Visits 1 and 5

    36 Days

Study Arms (1)

Experimental: carbidopa and levodopa

EXPERIMENTAL

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.

Drug: IPX054 100 mgDrug: IPX054 150 mgDrug: IPX054 200 mgDrug: IPX054 250 mgDrug: IPX054 300 mg

Interventions

IPX054 100 mgDRUG

IPX054 containing 25 mg carbidopa and 100 mg levodopa

Also known as: CD-LD ER 100 mg
Experimental: carbidopa and levodopa
IPX054 150 mgDRUG

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

Also known as: CD-LD ER 150 mg
Experimental: carbidopa and levodopa
IPX054 200 mgDRUG

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

Also known as: CD-LD ER 200 mg
Experimental: carbidopa and levodopa
IPX054 250 mgDRUG

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

Also known as: CD-LD ER 250 mg
Experimental: carbidopa and levodopa
IPX054 300 mgDRUG

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

Also known as: CD-LD ER 300 mg
Experimental: carbidopa and levodopa

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosed with atypical parkinsonism
  • Prior surgical interventions for Parkinson's disease
  • Glaucoma
  • Undiagnosed skin lesion or history of melanoma
  • Epilepsy or history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 101

Sunnyvale, California, 94089, United States

Location

Site 102

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Impax Study Director

    Impax Laboratories, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 29, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)