CLINICAL TRIALS PROFILE FOR PRELADENANT
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Clinical Trials for Preladenant
Trial ID | Title | Status | Sponsor | Phase | Summary |
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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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Preladenant
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Clinical Trial Progress for Preladenant
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Clinical Trial Sponsors for Preladenant
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