A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson*s Disease
- Conditions
- Parkinson Disease10028037
- Registration Number
- NL-OMON38067
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
• Subjects must have completed P04938.
• Each subject must be willing and able to provide written informed consent for
the P06153.
• Subjects must be able to adhere to dose and visit schedules.
• Subjects must be taking levodopa (L-dopa).
• Subjects may be taking any of the additional adjunct Parkinson Disease (PD) medications shown in the table below.
Note: Subjects taking only L-dopa are permitted to enroll in this trial.
Amantadine
Anticholinergics
Dopa decarboxylase inhibitors
Dopamine agonists
Entacapone
L-dopa
• Each subject 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), 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 subject 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 subjects that are sexually active or plan to be sexually active agree to use a highly effective method
of birth control while the subject is in the study and for 2 weeks after the last dose of study drug. A
male subject must not donate sperm within 2 weeks after the last dose of study drug. Complete details
regarding contraceptive requirements are specified in protocol Section 7.7.1.7.
• A subject must not have discontinued from P04938 for any reason.
• A subject must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant
cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
• A subject must not have poorly controlled diabetes ( eg, HbA1c *8.5) or significantly abnormal renal function
(eg, 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), any
subject 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 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 studies (P04938),
any subject meeting the following criteria for the second of two consecutive visits separated by 7 days (ie, the subject 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
• An elevation from Baseline BP in the parent study (P04938) of systolic BP *40 mm Hg or
diastolic BP *20 mm Hg.
• A subject must not have a history within the past 5 years of a primary or recurrent malignant disease with the
exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ
prostate cancer with a normal prostate-specific antigen (PSA) post resection.
• A subject must not have an average daily consumption of more than three 4-ounce glasses (180 mL) of wine or the equivalent.
• Prohibited Concomitant Medications: A subject should not take or start taking any treatment listed in the table on page 4 from the protocol.
A subject must not have received any treatment listed in the table below more recently than the
indicated period before Day 1 of P06153.
Note: Warnings and Contraindications detailed in the Prescribing Information for the allowed medications
(shown in the inclusion criteria) must be followed.
• A subject must not have allergy/sensitivity to the investigational products or their excipients.
• A female subject must not be breast-feeding or considering breast-feeding.
• A female subject must not be pregnant or intending to become pregnant.
• A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
• A subject must not be a member of or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Objective: to evaluate the efficacy of a range of preladenant<br /><br>doses during long term use in subjects with moderate to severe Parkinson*s<br /><br>disease (PD) experiencing motor fluctuations and receiving a stable dose of<br /><br>levodopa (L-dopa), as measured by *off* time. Primary Safety Objective: The<br /><br>Primary Safety Objective of this trial is to assess the safety and tolerability<br /><br>of preladenant compared with placebo in subjects with moderate to severe PD<br /><br>experiencing motor fluctuations and receiving a stable dose of L-dopa. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Key Secondary Trial Objectives: to evaluate the efficacy of a range of<br /><br>preladenant doses during long term use in subjects with moderate to severe PD<br /><br>experiencing motor fluctuations and receiving a stable dose of L-dopa as<br /><br>measured by *on* time without troublesome dyskinesia and by the proportion of<br /><br>Responders</p><br>