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

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

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE January 2, 2017
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE November 14, 2016
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Advanced Parkinson's Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2016)
30
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03007888
Other Study ID Numbers  ICMJE IPX203-B16-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Impax Laboratories, LLC
Study Sponsor  ICMJE Impax Laboratories, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Impax Study Director Impax Laboratories, LLC
PRS Account Impax Laboratories, LLC
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP