Status:
COMPLETED
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
Lead Sponsor:
Impax Laboratories, LLC
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The study had three distinct parts and is described as follows: Part 1: * To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advance...
Detailed Description
Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the s...
Eligibility Criteria
Inclusion
- Diagnosed with idiopathic PD without any known cause for Parkinsonism.
- At least 30 years old at the time of PD diagnosis.
- Currently being treated with:
- an LD dosing frequency of at least four times a day
- at least one dose of CD-LD ER daily
- requiring a total daily LD dose of at least 400 mg
- stable regimen for at least 4 weeks prior to Screening
- Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
Exclusion
- Pregnant or breastfeeding
- Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- Nonresponsive to LD therapy.
- Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- Any evidence of suicidal behavior within 6 months of entering the study.
- Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- History of or currently active psychosis.
- Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
- Active or history of narrow-angle glaucoma.
- History of malignant melanoma or a suspicious undiagnosed skin lesion.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
- Abnormal kidney function
- Severe hepatic impairment.
- Received any investigational medications during the 4 weeks prior to Screening.
- Previously enrolled in IPX066 studies.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01411137
Start Date
August 1 2011
End Date
March 1 2013
Last Update
November 7 2019
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Coastal Neurological Medical Group
La Jolla, California, United States, 92037
3
The Parkinson's Institute
Sunnyvale, California, United States, 94085
4
Renstar Medical Research
Ocala, Florida, United States, 34471