NCT00253084

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.

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_2

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
2 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

2.1 years

First QC Date

November 11, 2005

Last Update Submit

October 25, 2019

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • "ON" time without disabling dyskinesias

    2 weeks

Secondary Outcomes (3)

  • UPDRS analysis

    2 weeks

  • Mean time to "ON"

    2 weeks

  • Mean time to "wearing OFF"

    2 weeks

Study Arms (2)

IPX054 - CD-LD IR

OTHER

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.

Drug: IPX054 200 mgDrug: CD-LD IRDrug: IPX054 PlaceboDrug: CD-LD IR Placebo

CD-LD IR - IPX054

OTHER

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.

Drug: IPX054 200 mgDrug: CD-LD IRDrug: IPX054 PlaceboDrug: CD-LD IR Placebo

Interventions

IPX054 200 mgDRUG

IPX054 containing 50 mg carbidopa and 200 mg levodopa

Also known as: CD-LD ER 200 mg
CD-LD IR - IPX054IPX054 - CD-LD IR
CD-LD IRDRUG

CD-LD IR containing 25 mg carbidopa and 100 mg levodopa

CD-LD IR - IPX054IPX054 - CD-LD IR
IPX054 PlaceboDRUG

Placebo to match IPX054 200 mg

CD-LD IR - IPX054IPX054 - CD-LD IR
CD-LD IR PlaceboDRUG

Placebo to match CD-LD IR

CD-LD IR - IPX054IPX054 - CD-LD IR

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 1

Chicago, Illinois, 60612, United States

Location

Site 2

Charleston, South Carolina, 29425, 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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

November 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)