An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM3)



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2010
End Date:November 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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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)


The purpose of this trial is to assess safety data collected for up to 52 weeks (from the
beginning of P04938 or P07037 to the end of P06153) and to characterize the efficacy of
preladenant over the same time period in participants with moderate to severe Parkinson's
disease (PD).


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 levo-dopa (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., HbA1c > 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

- An elevation from baseline BP in the parent study (P04938 or P07037) of systolic BP
>= 40 mm Hg or diastolic BP ≥ 20 mm Hg.

- A participant 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.

- Any participant with an average daily consumption of more than three 4-ounce glasses
(118 mL) of wine or the equivalent.

- A participant must not have received certain prespecified medications or ingested
high tyramine-containing aged cheeses (e.g., Stilton) for a prespecified time window
before the trial, during the trial, and for 2 weeks after the trial.

- Any participant with allergy/sensitivity to the investigational products or their
excipients.

- Any female participant breast feeding or considering breast feeding.

- Any female participant pregnant or intending to become pregnant.

- Any participant with 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.

- Any participant with a member or a family member of the personnel of the
investigational or sponsor staff directly involved with this trial.
We found this trial at
39
sites
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Little Rock, AR
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Asheville, North Carolina 28806
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Asheville, NC
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Atlanta, GA
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Atlantis, FL
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Bingham, MI
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Boca Raton, FL
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Boston, MA
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Boulder, CO
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Bradenton, FL
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Charlotte, North Carolina 28204
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Charlotte, NC
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Commack, NY
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Decatur, GA
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Englewood, CO
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Fresno, CA
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Gilbert, AZ
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Henrico, VA
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Hollywood, FL
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Houston, TX
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Indianapolis, IN
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Kansas City, KS
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Long Beach, CA
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Milwaukee, WI
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Naples, FL
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New York, NY
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Orlando, FL
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Oxnard, CA
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Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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Phoenix, AZ
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Raleigh, NC
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Reseda, CA
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Santa Rosa, CA
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St. Louis, MO
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Sun City, AZ
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Sunrise, FL
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Tamarac, FL
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Toms River, NJ
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Tucson, AZ
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Tucson, AZ
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West Bloomfield, Michigan 48322
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West Bloomfield, MI
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