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An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)

NCT01215227•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who have completed the 12-week treatment period of the parent trial, P04938 or P07037.
•Participants must be willing and able to provide written informed consent for P06153.
•Participants must be able to adhere to dose and visit schedules.
•Participants must be taking L-dopa.
•Participants may be taking additional adjunct PD medications (e.g., dopamine agonists, entacapone).
•Each participant must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings.
•There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus \[CMV\], Epstein-Barr virus \[EBV\], and Hepatitis B, C, and E).
•Each participant must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure.
•All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must not donate sperm within 2 weeks after the last dose of study drug.

Exclusion Criteria

•Any participant who discontinued from P04938 or P07037 for any reason.
•Any participant with a severe or ongoing unstable medical condition (e.g., any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
•Any participant with a history of poorly controlled diabetes (e.g., hemoglobin A1c \> 8.5) or significantly abnormal renal function (e.g., creatinine \> 2.0 mg/dL) in the opinion of the investigator.
•As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any participant with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria:
•ALT or AST \> 8 x upper limit of normal (ULN).
•ALT or AST \> 5 x ULN for more than 2 weeks.
•ALT or AST \> 3 x ULN and (T-BIL \> 2 x ULN or international normalized ratio \[INR\] \> 1.5 that is not due to anti-coagulation) at the same visit.
•ALT or AST \> 3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (\> 5%).
•As a continuation of the blood pressure (BP) withdrawal criteria from the parent study (P04938 or P07037), any participant meeting the following criteria for the second of two consecutive visits separated by 7 days (i.e., the participant met one of the BP criteria once already, 7 days before the P06153 screening visit):
•Systolic BP ≥ 180 mm Hg or diastolic BP ≥ 105 mm Hg, or
+9 more criteria

Key Dates

Start Date

November 18, 2010

Primary Completion Date

July 16, 2013

Completion Date

July 16, 2013

Last Updated

November 6, 2018

Enrollment

839

ACTUAL participants

Conditions

Parkinson DiseaseIdiopathic Parkinson Disease

Interventions

Preladenant

DRUG

Rasagiline

DRUG

Placebo to preladenant

DRUG

Placebo to rasagiline

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients