Dyskinesia in Parkinson's Disease (Study P04501)

NCT ID: NCT00406029

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-20
• Study Completion Date: 2008-11-03

Brief Summary

The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.

Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

Conditions

Parkinson Disease; Movement Disorders; Central Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Preladenant 1 mg BID

Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

1 mg BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Preladenant 2 mg BID

Participants received preladenant 2 mg BID during the 12-week treatment period.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

2 mg BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Preladenant 5 mg BID

Participants received preladenant 5 mg BID during the 12-week treatment period.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

5 mg BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Preladenant 10 mg BID

Participants received preladenant 10 mg BID during the 12-week treatment period.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

10 mg BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Placebo BID

Participants received preladenant matching placebo BID during the 12-week treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BID capsules

L-dopa

Intervention Type: DRUG

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Other Parkinson's Disease treatments

Intervention Type: DRUG

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Interventions

Preladenant

1 mg BID capsules

Intervention Type: DRUG

Preladenant

2 mg BID capsules

Intervention Type: DRUG

Preladenant

5 mg BID capsules

Intervention Type: DRUG

Preladenant

10 mg BID capsules

Intervention Type: DRUG

Placebo

BID capsules

Intervention Type: DRUG

L-dopa

Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).

Intervention Type: DRUG

Other Parkinson's Disease treatments

Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Intervention Type: DRUG

Other Intervention Names

SCH 420814; SCH 420814; SCH 420814; SCH 420814

Eligibility Criteria

Inclusion Criteria

• Participants must be 30 years of age, of either sex and of any race, with a diagnosis of moderate to severe idiopathic Parkinson's disease for at least 5 years.
• Women of childbearing potential must have a negative serum pregnancy test at Visit 2 (Week -1). If participant is postmenopausal (not surgically induced), she must be postmenopausal by history for at least 2 years before study entry. If not, proper birth control must be used.

Note: Acceptable methods of birth control include oral or injectable hormonal contraceptive, medically prescribed intrauterine device (IUD), and double-barrier method (eg, condom in combination with spermicide). Bilateral tubal ligation is an acceptable method of birth control for this study.

• Participants' clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.

Exclusion Criteria

• Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment (Mini-Mental State Examination [MMSE] score <=23), a history of Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) diagnosed major depression, unstable mild depression or psychosis, or participants taking tolcapone will be excluded. (Participants with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.)
• All participants with a severe or ongoing unstable medical condition will be excluded including those with a history of poorly controlled diabetes, obesity associated with metabolic syndrome, uncontrolled hypertension, cerebrovascular disease, or any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, renal failure, history of abnormal renal function, seizures, alcohol/drug dependence, or previous surgery for Parkinson's disease.
• Average daily consumption of more than two 4-oz (120 mL) glasses of wine or their equivalent.
• Because it is not known whether preladenant passes into breast milk and because the effects, if any, of preladenant on the developing human are unknown, women who are breastfeeding or who are considering breastfeeding are excluded from this trial.
• Participants with allergy/sensitivity to study drug or its excipients.
• Participants with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
• Participants who have used any other investigational drugs within 30 days of Screening.
• Participants who are participating in any other clinical study.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hauser RA, Cantillon M, Pourcher E, Micheli F, Mok V, Onofrj M, Huyck S, Wolski K. Preladenant in patients with Parkinson's disease and motor fluctuations: a phase 2, double-blind, randomised trial. Lancet Neurol. 2011 Mar;10(3):221-9. doi: 10.1016/S1474-4422(11)70012-6.

Reference Type: DERIVED

PMID: 21315654 (View on PubMed)

Other Identifiers

MK-3814-013

Identifier Type: OTHER

Identifier Source: secondary_id

P04501

Identifier Type: -

Identifier Source: org_study_id