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An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

NCT01215227 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 839

Last updated 2018-11-06

Study results available
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Summary

The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 \[P04938\] and NCT01227265 \[P07037\] with moderate to severe Parkinson's Disease (PD). The study will also characterize the long-term efficacy of preladenant in participants with PD.

Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.

Conditions

  • Parkinson Disease
  • Idiopathic Parkinson Disease

Interventions

DRUG

Preladenant

Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)

DRUG

Rasagiline

Daily for 40 weeks: 1 mg rasagiline capsule each morning

DRUG

Placebo to preladenant

Placebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose)

DRUG

Placebo to rasagiline

Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning

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
2010-11-18
Primary Completion
2013-07-16
Completion
2013-07-16

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Companies

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 NCT01215227 on ClinicalTrials.gov