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

NCT ID: NCT03007888

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2017-08-01

Brief 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.

Conditions

Advanced Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPX203 then Sinemet

Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.

Group Type: EXPERIMENTAL

Sinemet

Intervention Type: DRUG

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

IPX203

Intervention Type: DRUG

Extended Release capsules containing carbidopa-levodopa flexible dosing

Sinemet then IPX203

Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.

Group Type: EXPERIMENTAL

Sinemet

Intervention Type: DRUG

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

IPX203

Intervention Type: DRUG

Extended Release capsules containing carbidopa-levodopa flexible dosing

Interventions

Sinemet

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

Intervention Type: DRUG

IPX203

Extended Release capsules containing carbidopa-levodopa flexible dosing

Intervention Type: DRUG

Other Intervention Names

IR CD-LD Tablets; IPX203 ER CD-LD Capsules

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Impax Laboratories, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Impax Study Director

Role: STUDY_DIRECTOR

Impax Laboratories, LLC

Locations

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

Investigator 104

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IPX203-B16-01

Identifier Type: -

Identifier Source: org_study_id