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

NCT ID: NCT00537017

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-23
• Study Completion Date: 2009-11-19

Brief Summary

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."

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preladenant 5 mg BID

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.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

5 mg BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.

Interventions

Preladenant

5 mg BID capsules

Intervention Type: DRUG

L-dopa

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Intervention Type: DRUG

Other Parkinson's Disease treatments

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.

Intervention Type: DRUG

Other Intervention Names

SCH 420814; Privadenant

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.

Reference Type: RESULT

PMID: 23589371 (View on PubMed)

Other Identifiers

MK-3814-021

Identifier Type: OTHER

Identifier Source: secondary_id

P05175

Identifier Type: -

Identifier Source: org_study_id