A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Advanced Parkinson's Disease
About this trial
This is an interventional treatment trial for Advanced Parkinson's Disease focused on measuring IPX203 (carbidopa-levodopa) Extended-Release capsules
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.
Sites / Locations
- Investigator 110
- Site 114
- Investigator 106
- Investigator 112
- Investigator 113
- Site 108
- Investigator 101
- Site 103
- Investigator 109
- Site 115
- Investigator 104
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
IPX203 then Sinemet
Sinemet then IPX203
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.
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.