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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:
IPX203 contains two different drugs called levodopa and carbidopa in one capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | 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. |
|
| Sequence 2 | Other | 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. |
|
| Sequence 3 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD-LD IR | Drug | CD-LD IR containing 25 mg carbidopa and 100 mg levodopa |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Off" time per the Assessment of Subject's Motor State | Up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 10 hours | |
| Change from predose value in the number of finger-taps at each timepoint |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Screening through end of study approximately 6 weeks per subject | |
| Maximum concentration (Cmax) | Up to 10 hours | |
| Area under the curve (AUC) |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Impax Study Director | Impax Laboratories, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhammad Ali Movement Disorder Center (MAMDC) | Phoenix | Arizona | 85013 | United States | ||
| Clinical Trials, Inc. |
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| IPX203 180 mg | Drug | IPX203 containing 45 mg carbidopa and180 mg levodopa |
|
|
| IPX203 270 mg | Drug | IPX203 containing 67.5 mg carbidopa and 270 mg levodopa |
|
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| Rytary 195 mg | Drug | Rytary 48.75Mg-195Mg Extended-Release Capsule |
|
| Rytary 145 mg | Drug | Rytary 36.25Mg-145Mg Extended-Release Capsule |
|
| Up to 10 hours |
| Up to 10 hours |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| The Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Collier Neurologic Specialists | Naples | Florida | 34102 | United States |
| University of South Florida Parkinson's Disease and Movement Disorder Center | Tampa | Florida | 33613 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Duke University Movement Disorders Clinic | Durham | North Carolina | 27705 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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