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

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:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	440
Study Start Date:	February 2011
Estimated Study Completion Date:	June 2013
Estimated 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01294800 History of Changes
Other Study ID Numbers:	P06402
Study First Received:	February 10, 2011
Last Updated:	March 8, 2013
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:

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 May 22, 2013