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View Clinical Trial (Medical Research Study)
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A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). - NCT00974974-77030 (Clinical Trial 422717)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy422717.aspx
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Parkinson's Disease |
| Purpose: |
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This is a study to evaluate the safety and efficacy of IPX066 in Advanced Parkinson's
Disease.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Baylor College of Medicine, Parkinson's Disease Center
Houston, TX 77030
United States
Primary Contact:
IPX066-B09-02 Study Coordinator
Phone: 713-798-5998 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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