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

NCT00537017 | Completed Phase 2 Results DMC

• 2 other identifiers: P05175MK-3814-021
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced at Least One Adverse Event

  An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.

  Up to 42 weeks

Secondary Outcomes (7)

• Time Spent in "Off" State Per Day

  Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36

• Awake Time Per Day in the "on" State

  Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36

• Time Spent in the "on" State With no Dyskinesias

  Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36

• Time Spent in the "on" State With Troublesome Dyskinesias

  Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36

• Time Spent in the "on" State Without Troublesome Dyskinesia

  Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36

Study Arms (1)

Preladenant 5 mg BID

EXPERIMENTAL

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.

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

Interventions

Preladenant DRUG

5 mg BID capsules

Also known as: SCH 420814; Privadenant

Preladenant 5 mg BID

L-dopa 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).

Preladenant 5 mg BID

Other Parkinson's Disease treatments 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.

Preladenant 5 mg BID

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23589371 RESULT

MeSH Terms

Conditions

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

Interventions

2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine; Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Nervous System Diseases; Synucleinopathies

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: November 23, 2007
• Primary Completion: November 19, 2009
• Study Completion: November 19, 2009
• Last Updated: February 2, 2021
• Results First Posted: December 6, 2016

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share