Phase 2
N=28
A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Advanced Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03007888 ↗Enrolled (actual)
28
Serious AEs
2.4%
Results posted
Jun 2022
Primary outcome: Primary: Levodopa Cmax Following First Dose on Day 1 — 2857.56; 2173.30 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sinemet (Drug); IPX203 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Impax Laboratories, LLC
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levodopa Cmax Following First Dose on Day 1 |
2857.56; 2173.30 | — |
| PRIMARY Levodopa Tmax Following First Dose on Day 1 |
2.07; 0.94 | — |
| PRIMARY Levodopa t1/2 Following First Dose on Day 1 |
1.658; 1.420 | — |
| PRIMARY Levodopa AUCt Following First Dose on Day 1 |
12107.60; 3747.61 | — |
| PRIMARY Levodopa AUCinf Following First Dose on Day 1 |
13968.57; 4308.37 | — |
| PRIMARY Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 |
88.965; 0 | — |
| PRIMARY Carbidopa Cmax Following First Dose on Day 1 |
500.35; 151.50 | — |
| PRIMARY Carbidopa Tmax Following First Dose on Day 1 |
2.61; 2.07 | — |
| PRIMARY Carbidopa t1/2 Following First Dose on Day 1 |
2.015; 1.969 | — |
| PRIMARY Carbidopa AUCt Following First Dose on Day 1 |
1940.51; 436.63 | — |
| PRIMARY Carbidopa AUCinf Following First Dose on Day 1 |
2239.61; 610.44 | — |
| PRIMARY Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 |
117.442; 0 | — |
| PRIMARY Levodopa Cmax Following First Dose on Day 15 |
2767.96; 2356.85 | — |
| PRIMARY Levodopa Tmax Following First Dose on Day 15 |
1.91; 0.83 | — |
| PRIMARY Levodopa AUCtau Following First Dose on Day 15 |
11213.76; 3879.39 | — |
| PRIMARY Carbidopa Cmax Following First Dose on Day 15 |
478.66; 145.67 | — |
| PRIMARY Carbidopa Tmax Following First Dose on Day 15 |
2.52; 2.20 | — |
| PRIMARY Carbidopa AUCtau Following First Dose on Day 15 |
1892.39; 415.83 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03007888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.