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Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037 AM3)

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: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Idiopathic Parkinson Disease
Idiopathic Parkinson's Disease
Drug: preladenant
Drug: Placebo to preladenant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 476
Study Start Date: November 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preladenant 2 mg twice daily Drug: preladenant
2 or 5 mg preladenant tablet twice daily
Other Name: SCH420814
Experimental: Preladenant 5 mg twice daily Drug: preladenant
2 or 5 mg preladenant tablet twice daily
Other Name: SCH420814
Placebo Comparator: Placebo twice daily Drug: Placebo to preladenant
Placebo tablet, orally, twice daily.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01227265     History of Changes
Other Study ID Numbers: P07037, 2010-020112-11
Study First Received: October 22, 2010
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014