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Trial record 1 of 1 for:    NCT03007888
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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

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.


Condition or disease Intervention/treatment Phase
Advanced Parkinson's Disease Drug: IR CD-LD Drug: ER CD-LD Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sequence 1
Treatment Period 1: ER CD-LD Capsules - 15 days; Washout Period 7-days; Treatment Period 2- IR CD-LD Tablet - 15 days
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

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




Primary Outcome Measures :
  1. Percentage off time during waking hours [ Time Frame: Last three days collected at the end of each treatment period ]
    Patient Diary


Secondary Outcome Measures :
  1. Off time and on time hours during in clinic observation [ Time Frame: Days 1 and 15 ]
    Subject Motor Assessment by site clinician

  2. MDS-UPDRS Part III [ Time Frame: Days 1 and 15 ]
    Based on MDS-UPDRS rating scale


Other Outcome Measures:
  1. Pharmacokinetics Cmax [ Time Frame: Day 1 and Day 15 of each treatment period. ]
  2. Pharmacokinetics AUC [ Time Frame: Day 1 and Day 15 of each treatment period. ]
  3. 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 ]
  4. 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.

  5. Safety and Tolerability as measured by change from baseline in ECGs [ Time Frame: Screening (baseline) through end of study, approximately 8 weeks per subject ]
  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007888


Locations
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United States, Arkansas
Investigator 110
Little Rock, Arkansas, United States, 72205
Site 114
Little Rock, Arkansas, United States, 72205
United States, Florida
Investigator 106
Boca Raton, Florida, United States, 33486
Investigator 112
Naples, Florida, United States, 34102
Investigator 113
Port Charlotte, Florida, United States, 33980
Site 108
Tampa, Florida, United States, 33613
United States, Michigan
Investigator 101
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Site 103
Durham, North Carolina, United States, 27705
United States, Ohio
Investigator 109
Cleveland, Ohio, United States, 44106
United States, Washington
Site 115
Kirkland, Washington, United States, 98034
Investigator 104
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Impax Laboratories, LLC
Investigators
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Study Director: Impax Study Director Impax Laboratories, LLC

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Responsible Party: Impax Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03007888    
Other Study ID Numbers: IPX203-B16-01
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Impax Laboratories, LLC:
IPX203 (carbidopa-levodopa) Extended-Release capsules
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists