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Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

NCT01227265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2018-09-24

Study results available
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Summary

This is a study of the efficacy and safety of preladenant in adult participants with moderate to severe Parkinson's Disease (PD). While on this study, participants will continue to take their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo, twice daily, for 12 weeks. After that, participants may choose to receive additional treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in the mean "off" time.

Conditions

  • Parkinson Disease
  • Idiopathic Parkinson Disease
  • Idiopathic Parkinson's Disease

Interventions

DRUG

Preladenant

Preladenant 2 mg or 5 mg oral tablet taken twice daily

DRUG

Placebo

Preladenant-matching placebo oral tablet taken twice daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-19
Primary Completion
2013-04-04
Completion
2013-04-16

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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 NCT01227265 on ClinicalTrials.gov