Status:
COMPLETED
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02271503
Start Date
November 1 2015
End Date
August 1 2016
Last Update
November 6 2019
Active Locations (11)
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1
Muhammad Ali Movement Disorder Center (MAMDC)
Phoenix, Arizona, United States, 85013
2
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
3
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
4
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486