Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyskinesias; Parkinsonian Disorders
Intervention: SCH 420814 10 mg; SCH 420814 100 mg; Placebo; Levodopa; Carbidopa
Intervention description: one 10-mg capsule, orally, at hour 0 of treatment period; single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period; Placebo capsule, oral, at hour 0 of treatment period; levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours; one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 conformance with Good Clinical Practices. This trial will investigate the
      effects of single doses of preladenant 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 (IV)
      levodopa infusion and oral carbidopa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.