Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Neurodegenerative Diseases; Movement Disorders; Central Nervous System Diseases; Parkinson Disease; Brain Diseases

Treatments: Drug: L-dopa; Drug: Other Parkinson's Disease treatments; Drug: Preladenant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537017

MK-3814-021 (Other Identifier)

P05175

Details and patient eligibility

About

The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."

Enrollment: 140 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have participated in P04501.
• Participants must be >=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
• Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.

Exclusion criteria

• Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
• Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
• Participants taking tolcapone
• Participants who are participating in any other clinical study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Preladenant 5 mg BID

Experimental group

Description:

Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.

Treatment:

Drug: Preladenant

Drug: L-dopa

Drug: Other Parkinson's Disease treatments