A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease - NCT00880620-92037A (Clinical Trial 284030)
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| City: |
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La Jolla |
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State:
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CA |
| Zip Code: |
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92037 |
| Conditions: |
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Parkinson's Disease |
| Purpose: |
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This study examines the efficacy of IPX066 as compared to placebo in Parkinson's disease.
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| Study summary: |
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A randomized, placebo controlled, fixed dose, parallel arm study of three doses of IPX066
versus placebo.
Approximately 350 subjects are equally randomized to receive one of 3 doses of IPX066, or
matching placebo, orally.
Sudy duration is approximately 30 weeks for each subject.
The UPDRS is the primary outcome measure. |
| Criteria: |
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Inclusion Criteria:
1. Able to understand and willing to voluntarily sign an informed consent form (ICF) and
Health Insurance Portability and Accountability Act (HIPAA) authorization or local
equivalent if applicable.
2. Diagnosed with idiopathic PD.
3. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase
inhibitors for more than 30 days and the exposure is not within 4 weeks prior to
study enrollment.
4. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type
B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to
Baseline, and agrees to maintain the stable regimen throughout study participation.
5. Agrees to use a medically acceptable method of contraception throughout the study and
for 1 month after completing the study.
6. Able and willing to comply with the protocol, including availability for all
scheduled clinic visits and telephone calls.
Exclusion Criteria:
1. Pregnant or breastfeeding.
2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated
during study participation.
4. Use of nonselective MAO inhibitors.
5. Use of dopamine agonists within 30 days prior to Screening.
6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
7. Treatment of psychosis with any antipsychotic.
8. History of seizure or epilepsy.
9. Active or prior medical condition or prior surgical procedure that would interfere
with LD absorption.
10. History of narrow-angle glaucoma.
11. Subjects with a history of malignant melanoma.
12. History of myocardial infarction with residual atrial, nodal, or ventricular
arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
13. Received any investigational medications during the 30 days prior to Screening. |
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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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February 17, 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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