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A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)

NCT01155479 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1022

Last updated 2018-11-07

Study results available
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Summary

This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).

Conditions

  • Parkinson Disease

Interventions

DRUG

Preladenant 2 mg tablet

Preladenant 2 mg oral tablet taken twice daily

DRUG

Preladenant 5 mg tablet

Preladenant 5 mg oral tablet taken twice daily

DRUG

Preladenant 10 mg tablet

Preladenant 10 mg oral tablet taken twice daily

DRUG

Rasagiline 1 mg capsule

Rasagiline 1 mg oral capsule taken once daily

DRUG

Placebo for Rasagiline 1 mg capsule

Placebo for rasagiline 1 mg oral capsule taken once daily

DRUG

Placebo for Preladenant

Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily

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
2010-07-06
Primary Completion
2013-07-16
Completion
2013-07-16

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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 NCT01155479 on ClinicalTrials.gov