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View Clinical Trial (Medical Research Study)
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Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients (Study P05550AM1) - NCT00845000-97239 (Clinical Trial 394743)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy394743.aspx
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| City: |
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Portland |
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State:
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OR |
| Zip Code: |
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97239 |
| Conditions: |
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Movement Disorders - Dyskinesias - Neurodegenerative Diseases - Central Nervous System Diseases - Brain Diseases |
| Purpose: |
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This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site,
third-party-blind study of SCH 420814 in patients with Parkinson disease to be conducted in
conformance with Good Clinical Practices. This trial will investigate the effects of single
doses of SCH 420814 and placebo on the dyskinesia and antiparkinsonian actions of a levodopa
infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug,
given as single, oral administrations in conjunction with intravenous levodopa infusion and
oral carbidopa.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Written informed consent; adhere to dose and visit schedules.
- Diagnosis of idiopathic PD from history, exam and relevant labs tests.
- Treated with L-dopa for >=1 yr.
- Motor fluctuations: changes in tapping speed between "on" and "off". Must be >=10%
tapping speed "on." A concurrent motor Unified Parkinson's Disease Rating Scale
(UPDRS): 20% improvement when "on."
- Dyskinesia when "on" measured >=2 on 0-4 (absent-severe) scale for four limbs, trunk,
neck and face (total 7 body parts and 28 points).
- Females: postmenopausal; and/or surgically sterilized, at Screening and negative
urine or serum pregnancy test each study visit; and/or premenopausal, unsterilized;
used medically accepted method of contraception for 2 mo contraception prior to
Screening; and agree to medically accepted method of contraception as above during
the trial (and screening period prior to receiving trial medication), and 2 mo after
stopping the trial medication. Vasectomy of partner not considered sufficient
contraception and require one of the approved methods. Females not currently sexually
active must consent to use one of the approved methods should they become sexually
active while participating in the study.
- Men: Use medically accepted method of contraception (above) or abstain from sexual
intercourse, during the trial and 2 mo after stopping the medication.
Exclusion Criteria:
- Female patients who are pregnant, intend to become pregnant (within 3 mo of ending
the study), or are lactating.
- Dementia (MMSE <23), hallucinations, confusion, major psychiatric disorders. |
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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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January 20, 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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