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

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ClinicalTrials.gov Identifier: NCT02271503
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.

Brief Summary:

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: CD-LD IR Drug: IPX203 180 mg Drug: IPX203 270 mg Drug: Rytary 195 mg Drug: Rytary 145 mg Phase 2

Detailed Description:

IPX203 contains two different drugs called levodopa and carbidopa in one capsule.

  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Other Name: Sinemet

Drug: IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
Other Name: CD-LD ER 180 mg

Drug: IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Other Name: CD-LD ER 270 mg

Drug: Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule

Drug: 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.
Drug: CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Other Name: Sinemet

Drug: IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
Other Name: CD-LD ER 180 mg

Drug: IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Other Name: CD-LD ER 270 mg

Drug: Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule

Drug: 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.
Drug: CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
Other Name: Sinemet

Drug: IPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
Other Name: CD-LD ER 180 mg

Drug: IPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Other Name: CD-LD ER 270 mg

Drug: Rytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule

Drug: Rytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule




Primary Outcome Measures :
  1. "Off" time per the Assessment of Subject's Motor State [ Time Frame: Up to 10 hours ]

Secondary Outcome Measures :
  1. Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed [ Time Frame: Up to 10 hours ]
  2. Change from predose value in the number of finger-taps at each timepoint [ Time Frame: Up to 10 hours ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: Screening through end of study approximately 6 weeks per subject ]
  2. Maximum concentration (Cmax) [ Time Frame: Up to 10 hours ]
  3. Area under the curve (AUC) [ Time Frame: Up to 10 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.

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:

Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.

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.


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): NCT02271503


Locations
United States, Arizona
Muhammad Ali Movement Disorder Center (MAMDC)
Phoenix, Arizona, United States, 85013
United States, Arkansas
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Collier Neurologic Specialists
Naples, Florida, United States, 34102
University of South Florida Parkinson's Disease and Movement Disorder Center
Tampa, Florida, United States, 33613
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Michigan
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Duke University Movement Disorders Clinic
Durham, North Carolina, United States, 27705
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Robert Rubens, MD IMPAX Laboratories, Inc.

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02271503     History of Changes
Other Study ID Numbers: IPX203-B14-02
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Carbidopa
Levodopa
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors