NCT00279825

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
1.9 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

1.9 years

First QC Date

January 18, 2006

Last Update Submit

October 25, 2019

Conditions

Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Alternate tapping of keys

    single dose

Secondary Outcomes (3)

  • Timed walking

    single dose

  • Tremor score

    single dose

  • Dyskinesia rating scale

    single dose

Study Arms (4)

Sequence 1

OTHER

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.

Drug: IPX054 200 mgDrug: IPX054 250 mgDrug: CD-LD IRDrug: CD-LD CRDrug: IPX054 200 mg PlaceboDrug: IPX054 250 mg PlaceboDrug: CD-LD IR PlaceboDrug: CD-LD CR Placebo

Sequence 2

OTHER

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.

Drug: IPX054 200 mgDrug: IPX054 250 mgDrug: CD-LD IRDrug: CD-LD CRDrug: IPX054 200 mg PlaceboDrug: IPX054 250 mg PlaceboDrug: CD-LD IR PlaceboDrug: CD-LD CR Placebo

Sequence 3

OTHER

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.

Drug: IPX054 200 mgDrug: IPX054 250 mgDrug: CD-LD IRDrug: CD-LD CRDrug: IPX054 200 mg PlaceboDrug: IPX054 250 mg PlaceboDrug: CD-LD IR PlaceboDrug: CD-LD CR Placebo

Sequence 4

OTHER

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.

Drug: IPX054 200 mgDrug: IPX054 250 mgDrug: CD-LD IRDrug: CD-LD CRDrug: IPX054 200 mg PlaceboDrug: IPX054 250 mg PlaceboDrug: CD-LD IR PlaceboDrug: CD-LD CR Placebo

Interventions

IPX054 200 mgDRUG

IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa

Sequence 1Sequence 2Sequence 3Sequence 4
IPX054 250 mgDRUG

IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa

Sequence 1Sequence 2Sequence 3Sequence 4
CD-LD IRDRUG

Active comparator containing 25 mg carbidopa and 100 mg levodopa

Also known as: Carbidopa-levodopa immediate-release tablets
Sequence 1Sequence 2Sequence 3Sequence 4
CD-LD CRDRUG

Active comparator containing 50 mg carbidopa and 200 mg levodopa

Also known as: Carbidopa-levodopa controlled-release tablets
Sequence 1Sequence 2Sequence 3Sequence 4
IPX054 200 mg PlaceboDRUG

Placebo to match IPX054 200 mg

Sequence 1Sequence 2Sequence 3Sequence 4
IPX054 250 mg PlaceboDRUG

Placebo to match IPX054 250 mg

Sequence 1Sequence 2Sequence 3Sequence 4
CD-LD IR PlaceboDRUG

Placebo to match CD-LD IR

Sequence 1Sequence 2Sequence 3Sequence 4
CD-LD CR PlaceboDRUG

Placebo to match CD-LD CR

Sequence 1Sequence 2Sequence 3Sequence 4

Eligibility Criteria

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

You may qualify if:

  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Oregon Health Sciences University - Parkinson's Center of Oregon

Portland, Oregon, 97239, 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

January 18, 2006

First Posted

January 20, 2006

Study Start

January 1, 2006

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)