A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
NCT ID: NCT02271503
Last Updated: 2019-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2015-11-30
2016-08-31
Brief Summary
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Objectives:
* Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
* Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
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Detailed Description
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* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1
Subject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3.
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule
Sequence 2
Subject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3.
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule
Sequence 3
Subject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3.
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule
Interventions
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CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.
Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.
Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.
Exclusion Criteria
Female subjects who are currently breastfeeding or lactating.
Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.
Allergic to study drugs
History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.
History of peptic ulcer disease or upper gastrointestinal hemorrhage.
History of narrow angle glaucoma.
History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.
History of psychosis.
Employees or family members of the Investigator, study site, or Sponsor.
Subjects who, in the opinion of the clinical investigator, should not participate in the study.
Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.
40 Years
ALL
No
Sponsors
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Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Impax Study Director
Role: STUDY_DIRECTOR
Impax Laboratories, LLC
Locations
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Muhammad Ali Movement Disorder Center (MAMDC)
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
University of South Florida Parkinson's Disease and Movement Disorder Center
Tampa, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Duke University Movement Disorders Clinic
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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IPX203-B14-02
Identifier Type: -
Identifier Source: org_study_id
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