Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037 AM3)
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | November 2010 |
End Date: | April 2013 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase 3, 12 Week, Double Blind, Placebo Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease. (Phase 3; Protocol No. P07037)
This is a study of the efficacy and safety of preladenant in adult participants with
moderate to severe Parkinson's Disease (PD). While on this study, participants will continue
to take their usual, prescribed, stable regimen of L-dopa or L-dopa plus adjunct PD
medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or
placebo, twice daily, for 12 weeks. After that, participants may choose to receive
additional treatment with preladenant.
Inclusion Criteria:
- Each participant must have a diagnosis of idiopathic Parkinson's disease.
- Each participant must have received prior therapy with L dopa for approximately 1 or
more years immediately before Screening and must continue to have a beneficial
clinical response to L-dopa.
- Each participant must have been on a stable dopaminergic treatment regimen for at
least the 5 weeks immediately before Randomization. Participants receiving other
adjunctive treatments (eg, dopamine agonist, anticholinergics) are permitted to
enroll in this trial. Participants taking only L dopa are permitted to enroll in this
trial.
- Each participant must be experiencing motor fluctuations with or without dyskinesias
within the 4 weeks immediately before Screening, must be experiencing a minimum of 2
hours/day of "off" time, and have a Hoehn & Yahr stage between 2.5 and 4 when in the
"on" state.
- Each participant, with or without the help of a caregiver, must be capable of
maintaining an accurate and complete symptom diary and to adhere to dose and visit
schedules.
- Each participant must have results of Screening clinical laboratory tests drawn
within 4 weeks prior to Randomization clinically acceptable to the investigator and
not within the parameters specified for exclusion (below).
- All participants who are sexually active or plan to be sexually active agree to use a
highly effective method of birth control while in the study and for 2 weeks after the
last dose of study drug. A male participant must also not donate sperm within 2 weeks
after the last dose of study drug.
Exclusion Criteria:
- A participant must not have a form of drug induced or atypical parkinsonism, a
cognitive impairment, bipolar disorder, untreated major depressive disorder,
schizophrenia, or other psychotic disorder; history exposure to a known neurotoxin,
or any neurological features not consistent with the diagnosis of PD as assessed by
the investigator.
- A participant must not have a history of repeated strokes or head injuries, or a
stroke within 6 months of Screening; poorly controlled diabetes; abnormal renal
function; or a severe or ongoing unstable medical condition.
- A participant must not have had surgery for their PD.
- A participant must not be at imminent risk of self-harm or harm to others.
- A participant must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP
≥95 mm Hg at Screening and at 2 BP rechecks prior to study start.
- A participant must not have had any clinically significant cardiovascular event or
procedure for 6 months prior to study start, including, but not limited to,
myocardial infarction, angioplasty, unstable angina, or heart failure; and a
participant must not have heart failure staged New York Heart Association Class III
or IV.
- A participant must not have an alanine aminotransferase (ALT) or aspartate amino
transferase (AST) ≥3 x the upper limit of normal (ULN) or total bilirubin (T BIL)
≥1.5 x ULN.
- A participant must not have a history of serologically confirmed hepatic dysfunction
(defined as viral infection [Hepatitis B or C; Epstein Barr virus (EBV);
cytomegalovirus (CMV)]) or a history of diagnosis of drug or alcohol induced hepatic
toxicity or frank hepatitis.
- 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.
- A participant must not have received certain prespecified medications for a
prespecified time window before the trial.
- A participant must not have an average daily consumption of more than three 4 ounce
glasses (118 mL) of wine or the equivalent.
- A participant 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 participant must not have allergy/sensitivity to investigational product(s) or
its/their excipients.
- A participant must not be breast-feeding, considering breast-feeding, pregnant, or
intending to become pregnant.
- A participant must not have used preladenant ever, or any investigational drugs
within 90 days immediately before Screening.
We found this trial at
40
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