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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:March 2011

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A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

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

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 enter a 3-week dose-adjustment period for regular CD-LD, followed by
a 6-week dose-conversion period to IPX066.

Inclusion Criteria:

1. Diagnosed with idiopathic PD.

2. At least 30 years old at the time of PD diagnosis.

3. 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.

4. Able to differentiate "on" state from "off" state.

5. Have predictable "off" periods.

6. 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.

7. Agrees to use a medically acceptable method of contraception throughout the study and
for 1 month afterward.

Exclusion Criteria:

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.

2. Nonresponsive to LD therapy.

3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain
stimulation) or if such procedures are anticipated during study participation.

4. 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.

5. Allergic to Yellow Dye #5 (tartrazine).

6. History of or currently active psychosis.

7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g.,
bowel) procedures that would interfere with LD absorption.

8. Active or history of narrow-angle glaucoma.

9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.

10. History of myocardial infarction with residual atrial, nodal, or ventricular
arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome
and/or nontraumatic rhabdomyolysis.

11. Received any investigational medications during the 4 weeks prior to Screening.

12. Unable to swallow large pills (e.g., large vitamin pills).

13. Pregnant or breastfeeding.

14. Subjects who are unable to complete a symptom diary.
We found this trial at
36
sites
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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3924 9th Avenue West
Bradenton, Florida 34205
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Augusta, GA
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Bingham Farms, Michigan 48025
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, IL
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Cincinatti, Ohio 45219
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Commack, New York 11725
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Hollywood, Florida 33021
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La Jolla, California 92037
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Little Rock, Arkansas 72205
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London,
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New Haven, Connecticut 06510
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Phoenix, Arizona 85013
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Port Charlotte, Florida 33980
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Raleigh, North Carolina 27607
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Saint Petersburg, Florida 33713
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Sunnyvale, California 94089
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Tacoma, Washington 98409
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Torrance, California 90502
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