Parkinson's Disease
Conditions
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.
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.
Interventions
DRUGCD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
DRUGIPX203 180 mg
IPX203 containing 45 mg carbidopa and180 mg levodopa
DRUGIPX203 270 mg
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
DRUGRytary 195 mg
Rytary 48.75Mg-195Mg Extended-Release Capsule
DRUGRytary 145 mg
Rytary 36.25Mg-145Mg Extended-Release Capsule
Sponsors
Impax Laboratories, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Off time per the Assessment of Subject's Motor State | Up to 10 hours |
Secondary
| Measure | 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 | Up to 10 hours |
Other
| Measure | 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) | Up to 10 hours |
Countries
United States
Outcome results
None listed