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

• ClinicalTrials.gov Identifier: NCT03007888
• Recruitment Status: Completed
• First Posted: January 2, 2017
• Last Update Posted: November 6, 2019
• Sponsor: Impax Laboratories, LLC
• Information provided by (Responsible Party): Impax Laboratories, LLC

Tracking Information

• First Submitted Date: December 6, 2016
• First Posted Date: January 2, 2017
• Last Update Posted Date: November 6, 2019
• Actual Study Start Date: November 14, 2016
• Actual Primary Completion Date: August 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 28, 2016)

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

Patient Diary

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 28, 2016)

• Off time and on time hours during in clinic observation [ Time Frame: Days 1 and 15 ]
  Subject Motor Assessment by site clinician
• MDS-UPDRS Part III [ Time Frame: Days 1 and 15 ]
  Based on MDS-UPDRS rating scale

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 28, 2016)

• Pharmacokinetics Cmax [ Time Frame: Day 1 and Day 15 of each treatment period. ]
• Pharmacokinetics AUC [ Time Frame: Day 1 and Day 15 of each treatment period. ]
• Safety and Tolerability as measured by the Incidence of Treatment-Emergent Adverse Events [ Time Frame: Screening through end of study, approximately 8 weeks per subject ]
• Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Screening through end of study, approximately 8 weeks per subject ]
  This rating scale measures the occurrence of suicidal ideation and behavior events of clinical trial participants.
• Safety and Tolerability as measured by change from baseline in ECGs [ Time Frame: Screening (baseline) through end of study, approximately 8 weeks per subject ]
• Safety and Tolerability as measured by change from baseline in clinical laboratory tests [ Time Frame: Screening (baseline) through end of study, approximately 8 weeks per subject ]
• Safety and Tolerability as measured by change from baseline in vital signs [ Time Frame: Screening (baseline) through end of study, approximately 8 weeks per subject ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
• Official Title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Advanced Parkinson's Disease

Intervention

• Drug: IR CD-LD
  Immediate Release Tablet containing carbidopa-levodopa flexible dosing
• Drug: ER CD-LD
  Extended Release capsules containing carbidopa-levodopa flexible dosing
  Other Name: IPX203

Study Arms

• Sequence 1
  Treatment Period 1: ER CD-LD Capsules - 15 days; Washout Period 7-days; Treatment Period 2- IR CD-LD Tablet - 15 days
  Interventions:

  • Drug: IR CD-LD
  • Drug: ER CD-LD
• Sequence 2
  Treatment Period 1- IR CD-LD Tablet - 15 days; Washout Period 7-days; Treatment Period 2- ER CD-LD Capsules - 15 days
  Interventions:

  • Drug: IR CD-LD
  • Drug: ER CD-LD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 7, 2017): 28
• Original Estimated Enrollment (submitted: December 28, 2016): 30
• Actual Study Completion Date: August 1, 2017
• Actual Primary Completion Date: August 1, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03007888
• Other Study ID Numbers: IPX203-B16-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Impax Laboratories, LLC
• Study Sponsor: Impax Laboratories, LLC
• Collaborators: Not Provided

Investigators

• Study Director: Impax Study Director; Impax Laboratories, LLC

• PRS Account: Impax Laboratories, LLC
• Verification Date: August 2018