Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550 AM3)
This study has been completed.
Sponsor:
Merck
Collaborator:
Oregon Health and Science University
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00845000
First received: February 13, 2009
Last updated: March 22, 2013
Last verified: March 2013
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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:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Levodopa
U.S. FDA Resources
Further study details as provided by Merck:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, 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 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dyskinesias Parkinson Disease Parkinsonian Disorders Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013