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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03007888
• Date of registration: 06/12/2016
• Prospective Registration: No
• Primary sponsor: Impax Laboratories, LLC
• Public title: A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
• Scientific title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
• Date of first enrolment: November 14, 2016
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03007888
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Impax Study Director
• Affiliation: Impax Laboratories, LLC

Key inclusion & 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.



Age minimum: 40 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Drug: ER CD-LD

Drug: IR CD-LD

Primary Outcome(s)

Percentage off time during waking hours [Time Frame: Last three days collected at the end of each treatment period]

Secondary Outcome(s)

MDS-UPDRS Part III [Time Frame: Days 1 and 15]

Off time and on time hours during in clinic observation [Time Frame: Days 1 and 15]

Secondary ID(s)

IPX203-B16-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors