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

NCT ID: NCT00845000

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-21
• Study Completion Date: 2010-05-14

Brief Summary

This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SCH 420814 10 mg→SCH 420814 100 mg→Placebo

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

SCH 420814 100 mg→Placebo→ SCH 420814 10 mg

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

Placebo→SCH 420814 10 mg→SCH 420814 100 mg

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

SCH 420814 100 mg→ SCH 420814 10 mg→Placebo

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

Placebo→ SCH 420814 100 mg→SCH 420814 10 mg

Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.

Group Type: EXPERIMENTAL

SCH 420814 10 mg

Intervention Type: DRUG

one 10-mg capsule, orally, at hour 0 of treatment period

SCH 420814 100 mg

Intervention Type: DRUG

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Placebo

Intervention Type: DRUG

Placebo capsule, oral, at hour 0 of treatment period

Levodopa

Intervention Type: DRUG

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Carbidopa

Intervention Type: DRUG

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

Interventions

SCH 420814 10 mg

one 10-mg capsule, orally, at hour 0 of treatment period

Intervention Type: DRUG

SCH 420814 100 mg

single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period

Intervention Type: DRUG

Placebo

Placebo capsule, oral, at hour 0 of treatment period

Intervention Type: DRUG

Levodopa

levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours

Intervention Type: DRUG

Carbidopa

one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-3814-023

Identifier Type: OTHER

Identifier Source: secondary_id

P05550

Identifier Type: -

Identifier Source: org_study_id