Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00845000
First received: February 13, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in patients with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.


Condition Intervention Phase
Parkinson Disease
Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the dyskinesia score versus time curve (AUC) [ Time Frame: Hours 1 through 6 on Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the tapping score versus time curve (AUC) [ Time Frame: Hours 1 through 6 on Day 1 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Treatment A, then Treatment B, then Treatment C
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Experimental: Sequence 2
Treatment A, then Treatment C, then Treatment B
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Experimental: Sequence 3
Treatment B, then Treatment A, then Treatment C
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Experimental: Sequence 4
Treatment B, then Treatment C, then Treatment A
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Experimental: Sequence 5
Treatment C, then Treatment A, then Treatment B
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Experimental: Sequence 6
Treatment C, then Treatment B, then Treatment A
Drug: Treatment A
One dose of 10 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Other Name: SCH 420814
Drug: Treatment B
One dose of 100 mg Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)
Drug: Treatment C
One dose of placebo matching Preladenant, Levodopa infusion (IV), and 25-mg oral Carbidopa administered three times daily (TID)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
  • Participants must have been treated with levodopa for one or more years
  • Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
  • Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
  • Participant must be free of any clinically significant disease that would interfere with the study evaluations
  • Female participants must be postmenopausal and/or surgically sterilized and have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test upon each admission to the study center
  • Premenopausal, unsterilized female participants have to agree to use a medically accepted method of contraception
  • Male participants must agree to use a medically accepted method of contraception as or abstain from sexual intercourse during the trial and for 2 months after stopping the medication.

Exclusion Criteria:

  • Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
  • Participants with dementia (mini-mental state examination [MMSE] <23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
  • Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
  • Participants with a positive screen for drugs of abuse
  • Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
  • Participants who are currently participating in another medical interventional clinical study or have participated in a medical interventional clinical study within 30 days and who have previously received this compound.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00845000     History of Changes
Other Study ID Numbers: P05550
Study First Received: February 13, 2009
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014