Trial record 1 of 2 for:    p07037
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Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01227265
First received: October 22, 2010
Last updated: September 9, 2014
Last verified: September 2014

October 22, 2010
September 9, 2014
November 2010
April 2013   (final data collection date for primary outcome measure)
Change from Baseline to Week 12 in mean "off" time in hours per day [ Time Frame: 12 weeks (Week 12 is End of Treatment) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01227265 on ClinicalTrials.gov Archive Site
  • Mean change from Baseline to Week 12 in "on" time without troublesome dyskinesias in hours per day. [ Time Frame: 12 weeks (Week 12 is End of Treatment) ] [ Designated as safety issue: No ]
  • The proportion of Responders, where Responder is defined as a participant with at least a 30% reduction in mean "off" time from Baseline to End of Treatment (Week 12). [ Time Frame: 12 weeks (Week 12 is End of Treatment) ] [ Designated as safety issue: No ]
  • Mean change from Baseline to Week 12 in "on" time without troublesome dyskinesias in hours per day. [ Time Frame: 12 weeks (Week 12 is End of Treatment) ] [ Designated as safety issue: No ]
  • The proportion of Responders, where Responder is defined as a subject with at least a 30% reduction in mean "off" time from Baseline to End of Treatment (Week 12). [ Time Frame: 12 weeks (Week 12 is End of Treatment) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Parkinson Disease
  • Idiopathic Parkinson Disease
  • Idiopathic Parkinson's Disease
  • Drug: preladenant
    2 or 5 mg preladenant tablet twice daily
    Other Name: SCH420814
  • Drug: Placebo to preladenant
    Placebo tablet, orally, twice daily.
  • Experimental: Preladenant 2 mg twice daily
    Intervention: Drug: preladenant
  • Experimental: Preladenant 5 mg twice daily
    Intervention: Drug: preladenant
  • Placebo Comparator: Placebo twice daily
    Intervention: Drug: Placebo to preladenant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
476
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01227265
P07037, 2010-020112-11
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP