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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03007888
Recruitment Status : Completed
First Posted : January 2, 2017
Results First Posted : June 6, 2022
Last Update Posted : June 6, 2022
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: Sinemet Drug: IPX203 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

Drug Information available for: Carbidopa

Arm Intervention/treatment
Experimental: IPX203 then Sinemet
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.
Drug: Sinemet
Immediate Release Tablet containing carbidopa-levodopa flexible dosing
Other Name: IR CD-LD Tablets

Drug: IPX203
Extended Release capsules containing carbidopa-levodopa flexible dosing
Other Name: IPX203 ER CD-LD Capsules

Experimental: Sinemet then IPX203
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.
Drug: Sinemet
Immediate Release Tablet containing carbidopa-levodopa flexible dosing
Other Name: IR CD-LD Tablets

Drug: IPX203
Extended Release capsules containing carbidopa-levodopa flexible dosing
Other Name: IPX203 ER CD-LD Capsules




Primary Outcome Measures :
  1. Levodopa Cmax Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  2. Levodopa Tmax Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  3. Levodopa t1/2 Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  4. Levodopa AUCt Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  5. Levodopa AUCinf Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  6. Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  7. Carbidopa Cmax Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  8. Carbidopa Tmax Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  9. Carbidopa t1/2 Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  10. Carbidopa AUCt Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  11. Carbidopa AUCinf Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  12. Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 [ Time Frame: Day 1 ]
    Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose

  13. Levodopa Cmax Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

  14. Levodopa Tmax Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

  15. Levodopa AUCtau Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

  16. Carbidopa Cmax Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

  17. Carbidopa Tmax Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.

  18. Carbidopa AUCtau Following First Dose on Day 15 [ Time Frame: Day 15 ]
    Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  Study Documents (Full-Text)

Documents provided by Impax Laboratories, LLC:
Study Protocol  [PDF] October 5, 2016
Statistical Analysis Plan  [PDF] September 29, 2017

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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
Results First Posted: June 6, 2022
Last Update Posted: June 6, 2022
Last Verified: February 2022
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
Synucleinopathies
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action