A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Key facts

Study ID

NCT00974974

Run by

Impax Laboratories, LLC

People needed

471

Starts

2009-09-01

Expected to finish

2011-03-01

Last updated by the study team

2020-08-11

Who can join

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

You may qualify if…

• Diagnosed with idiopathic PD.
• At least 30 years old at the time of PD diagnosis.
• Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
• Requiring a total daily IR LD dose of at least 400 mg
• Having a minimum dosing frequency of four times per day.
• Able to differentiate "on" state from "off" state.
• Have predictable "off" periods.
• Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are 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 afterward.

You may not qualify if…

• 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.
• Received within 4 weeks or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
• Allergic to Yellow Dye #5 (tartrazine).
• History of or currently active psychosis.
• Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
• Active or history of narrow-angle glaucoma.
• A 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.
• Received any investigational medications during the 4 weeks prior to Screening.
• Unable to swallow large pills (e.g., large vitamin pills).
• Pregnant or breastfeeding.
• Subjects who are unable to complete a symptom diary.

Where it is running

• Investigator 49 — Phoenix, Arizona, United States
• Investigator 7 — Little Rock, Arkansas, United States
• Investigator 3 — La Jolla, California, United States
• Investigator 31 — Sunnyvale, California, United States
• Investigator 6 — Torrance, California, United States
• Investigator 51 — Aurora, Colorado, United States
• Investigator 10 — New Haven, Connecticut, United States
• Investigator 64 — Bradenton, Florida, United States
• Investigator 61 — Hollywood, Florida, United States
• Investigator 5 — Ocala, Florida, United States
• Investigator 15 — Port Charlotte, Florida, United States
• Investigator 8 — Port Charlotte, Florida, United States
• Investigator 4 — St. Petersburg, Florida, United States
• Investigator 46 — Augusta, Georgia, United States
• Investigator 38 — Boise, Idaho, United States
• Investigator 19 — Chicago, Illinois, United States
• Investigator 40 — Chicago, Illinois, United States
• Investigator 39 — Des Moines, Iowa, United States
• Investigator 29 — Kansas City, Kansas, United States
• Investigator 1 — Bingham Farms, Michigan, United States
• Investigator 21 — New Brunswick, New Jersey, United States
• Investigator 25 — Albany, New York, United States
• Investigator 8 — Commack, New York, United States
• Investigator 12 — New York, New York, United States
• Investigator 17 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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