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A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)

NCT01155466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 778

Last updated 2018-11-06

Study results available
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Summary

When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time.

Conditions

  • Parkinson Disease

Interventions

DRUG

Preladenant 2 mg tablet

one 2 mg tablet orally twice daily

DRUG

Preladenant 5 mg tablet

one 5 mg tablet orally twice daily

DRUG

Preladenant 10 mg tablet

one 10 mg tablet orally twice daily

DRUG

Placebo to Preladenant Tablet

one tablet orally twice daily

DRUG

Rasagiline 1 mg capsule

one 1 mg capsule orally in AM

DRUG

Placebo to Rasagiline capsule

one capsule orally in AM

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-07-14
Primary Completion
2012-12-20
Completion
2012-12-20

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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 NCT01155466 on ClinicalTrials.gov