Comparison of IPX054 and Immediate-Release Carbidopa-Levo... | NCT00253084

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

NCT00253084

Sponsor

Impax Laboratories, LLC

Status

Completed

Last Update Posted

Oct 29, 2019Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

IPX054 200 mg
CD-LD IR
IPX054 Placebo
CD-LD IR Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 11, 2005

First Submission Date that Met QC Criteria

Nov 11, 2005

First Posted Date

Nov 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 mg Drug: CD-LD IR Drug: IPX054 Placebo Drug: 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 mg Drug: CD-LD IR Drug: IPX054 Placebo Drug: CD-LD IR Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPX054 200 mg	Drug	IPX054 containing 50 mg carbidopa and 200 mg levodopa	CD-LD IR - IPX054 IPX054 - CD-LD IR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"ON" time without disabling dyskinesias		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
UPDRS analysis		2 weeks
Mean time to "ON"		2 weeks
Mean time to "wearing OFF"

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Impax Study Director	Impax Laboratories, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 1		Chicago	Illinois	60612	United States
Site 2

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided