A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01294800
First received: February 10, 2011
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

This study is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with moderate to severe Parkinson's disease (PD) experiencing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time


Condition Intervention Phase
Parkinson's Disease
Drug: Preladenant
Drug: Placebo tablet to match Preladenant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from Baseline to End of Treatment (Week 12) in mean "off" time in hours per day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with 30% reduction in "off" time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in "on" time without troublesome dyskinesias measured in hours per day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preladenant 2mg Drug: Preladenant
2, 5, or 10 mg tablets taken orally twice daily (BID)
Other Name: SCH 420814
Experimental: Preladenant 5mg Drug: Preladenant
2, 5, or 10 mg tablets taken orally twice daily (BID)
Other Name: SCH 420814
Experimental: Preladenant 10mg Drug: Preladenant
2, 5, or 10 mg tablets taken orally twice daily (BID)
Other Name: SCH 420814
Placebo Comparator: Placebo Drug: Placebo tablet to match Preladenant
tablets taken orally BID

  Eligibility

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

Inclusion Criteria:

  • Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease Society Brain Bank Criteria, judged to be moderate to severe
  • Must have received prior therapy with L-dopa for more than 1 year before Screening
  • Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum

therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization

  • If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization
  • Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening
  • Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of

treatment medications and within the 4 weeks immediately before Screening

- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator

and supported by the symptom diary (Daily Diary) at the Diary Training Visit

- With or without the help of a caregiver, must be capable of maintaining an accurate and

complete symptom diary (Daily Diary) as assessed at the Diary Training Visit

- Must have results of Screening clinical laboratory tests (complete blood count [CBC], blood

chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening

- Must have results of a physical examination within normal limits or clinically acceptable limits

to the investigator

  • Must be able to adhere to dose and visit schedules
  • Females of child-bearing potential must have a negative serum pregnancy test (human chorionic

gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication

Exclusion Criteria:

  • Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
  • Must not have had surgery for PD
  • Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual

of Mental Disorders IV Text Revision (DSM-IV-TR) criteria

- Must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on

clinical interview

  • Must not have participated in any studies using preladenant
  • Must not have allergy/sensitivity to preladenant or any of its excipients
  • Must not have used any investigational drugs or participated in any other clinical trial within 90 days of 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: NCT01294800     History of Changes
Other Study ID Numbers: P06402
Study First Received: February 10, 2011
Last Updated: July 19, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Parkinson's disease

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 21, 2014