CLINICAL TRIALS PROFILE FOR PRELADENANT
✉ Email this page to a colleague
Clinical Trials for Preladenant
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00406029 ↗ | Dyskinesia in Parkinson's Disease (Study P04501) | Completed | Merck Sharp & Dohme Corp. | Phase 2 | 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. |
| NCT00537017 ↗ | Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) | Completed | Merck Sharp & Dohme Corp. | Phase 2 | The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias." |
| NCT00686699 ↗ | Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628) | Terminated | Merck Sharp & Dohme Corp. | Phase 2 | This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom Rating Score (ESRS), was to be evaluated frequently during the treatment periods. |
| NCT00693472 ↗ | Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145) | Terminated | Merck Sharp & Dohme Corp. | Phase 2 | This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale. |
| NCT00845000 ↗ | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Completed | Oregon Health and Science University | Phase 1 | 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. |
| NCT00845000 ↗ | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Completed | Merck Sharp & Dohme Corp. | Phase 1 | 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. |
| NCT01155466 ↗ | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Preladenant
Condition Name
Clinical Trial Locations for Preladenant
Trials by Country
Clinical Trial Progress for Preladenant
Clinical Trial Phase
Clinical Trial Sponsors for Preladenant
Sponsor Name
