Status:
COMPLETED
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
Detailed Description
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT00974974
Start Date
September 1 2009
End Date
March 1 2011
Last Update
August 11 2020
Active Locations (73)
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1
Investigator 17
Birmingham, Alabama, United States, 35233
2
Investigator 49
Phoenix, Arizona, United States, 85013
3
Investigator 7
Little Rock, Arkansas, United States, 72205
4
Investigator 3
La Jolla, California, United States, 92037