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

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Advanced Parkinson's Disease

Treatments: Drug: Sinemet; Drug: IPX203

Study type: Interventional

Funder types: Industry

Identifiers

NCT03007888

IPX203-B16-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility will be determined at screening and Visit 1 of the study.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

IPX203 then Sinemet

Experimental group

Description:

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.

Treatment:

Drug: IPX203

Drug: Sinemet

Sinemet then IPX203

Experimental group

Description:

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.

Treatment:

Drug: IPX203

Drug: Sinemet