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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01215227
First received: October 4, 2010
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Parkinson Disease
Idiopathic Parkinson Disease
Drug: Preladenant
Drug: Rasagiline
Drug: Placebo to preladenant
Drug: Placebo to rasagiline
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of systolic blood pressure (SBP) ≥ 180 mmHg [ Time Frame: Up to 42 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]
  • Incidence of diastolic blood pressure (DBP) ≥ 105 mmHg [ Time Frame: Up to 42 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]
  • Incidence of alanine aminotransferase (ALT) ≥ 3 times upper limit of normal and with a ≥10% increase from baseline [ Time Frame: Up to 42 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]
  • Incidence of aspartate aminotransferase (AST) ≥ 3 times upper limit of normal and with a ≥10% increase from baseline [ Time Frame: Up to 42 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (CSSRS): Suicidality, Suicidal Behavior, Suicidal Ideation [ Time Frame: Up to 40 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]
  • Epworth Sleepiness Scale Score [ Time Frame: Screening and 40 weeks from the beginning of P06153 ] [ Designated as safety issue: Yes ]

Enrollment: 841
Study Start Date: November 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preladenant 2 mg Drug: Preladenant
Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
Other Name: SCH 420814
Drug: Placebo to rasagiline
Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning
Experimental: Preladenant 5 mg Drug: Preladenant
Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
Other Name: SCH 420814
Drug: Placebo to rasagiline
Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning
Experimental: Preladenant 10 mg Drug: Preladenant
Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
Other Name: SCH 420814
Drug: Placebo to rasagiline
Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning
Active Comparator: Rasagiline 1 mg Drug: Rasagiline
Daily for 40 weeks: 1 mg rasagiline capsule each morning
Other Name: Azilect®
Drug: Placebo to preladenant
Placebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose)

  Eligibility

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

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215227

  Show 50 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01215227     History of Changes
Other Study ID Numbers: P06153, 2009-015162-57
Study First Received: October 4, 2010
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014