Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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 advanced PD * To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects. Part 2: • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study. Part 3: • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.

Key facts

Study ID

NCT01411137

Run by

Impax Laboratories, LLC

People needed

43

Starts

2011-08-01

Expected to finish

2013-03-01

Last updated by the study team

2019-11-07

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Coastal Neurological Medical Group — La Jolla, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Renstar Medical Research — Ocala, Florida, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Parkinson's Disease and Movement Disorders Center of Long Island — Commack, New York, United States
• Wisconsin Institute for Neurologic and Sleep Disorders — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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