Status:
COMPLETED
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in ...
Eligibility Criteria
Inclusion
- Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
- Participants must have been treated with levodopa for one or more years
- Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
- Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
- Participant must be free of any clinically significant disease that would interfere with the study evaluations
- Female participants must be postmenopausal and/or surgically sterilized and have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test upon each admission to the study center
- Premenopausal, unsterilized female participants have to agree to use a medically accepted method of contraception
- Male participants must agree to use a medically accepted method of contraception as or abstain from sexual intercourse during the trial and for 2 months after stopping the medication.
Exclusion
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
- Participants with dementia (mini-mental state examination \[MMSE\] \<23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
- Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Participants with a positive screen for drugs of abuse
- Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Participants who are currently participating in another medical interventional clinical study or have participated in a medical interventional clinical study within 30 days and who have previously received this compound.
Key Trial Info
Start Date :
April 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00845000
Start Date
April 21 2009
End Date
May 14 2010
Last Update
November 7 2018
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