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A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

NCT03007888•Impax Laboratories, LLC

View on ClinicalTrials.gov

Summary

Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.

Detailed Description

IPX203 is an investigational product containing CD-LD. IPX203-B16-01 Study Design: A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study. Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized. The study duration will be approximately 8 weeks, including the screening period.

Eligibility

Age

40 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility will be determined at screening and Visit 1 of the study.
•Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
•Hoehn and Yahr Stages 2, 3, or 4
•Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
•For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
•Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
•Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
•By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours

Exclusion Criteria

•History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
•Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
•History of drug or alcohol abuse within the 12 months prior to Screening.
•Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
•History of psychosis within the past 10 years.
•Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
•Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.

Locations (11)

Investigator 110

Little Rock, Arkansas, United States

Site 114

Little Rock, Arkansas, United States

Investigator 106

Boca Raton, Florida, United States

Investigator 112

Naples, Florida, United States

Investigator 113

Port Charlotte, Florida, United States

Site 108

Tampa, Florida, United States

Investigator 101

Farmington Hills, Michigan, United States

Site 103

Durham, North Carolina, United States

Investigator 109

Cleveland, Ohio, United States

Site 115

Kirkland, Washington, United States

Key Dates

Start Date

November 14, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

June 6, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Parkinson's Disease

Interventions

Sinemet

DRUG

IPX203

DRUG

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

NCT07422675

PARKINSON DISEASE (Disorder)Advanced Parkinson's Disease

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COMPLETEDPHASE3

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

NCT01723904

Advanced Parkinson's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease