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Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)

NCT00845000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-07

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

SCH 420814 10 mg

one 10-mg capsule, orally, at hour 0 of treatment period

DRUG

SCH 420814 100 mg

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

DRUG

Placebo

Placebo capsule, oral, at hour 0 of treatment period

DRUG

Levodopa

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

DRUG

Carbidopa

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-21
Primary Completion
2010-04-30
Completion
2010-05-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845000 on ClinicalTrials.gov