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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00406029 |
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. SCH 420814 is a drug that may prove to be effective in treating Parkinson's disease, and therefore we are currently gathering data to allow us to gain approval from the FDA and/or other Health Authorities, so that SCH 420814 can be used to treat patients in the future. In this study, we will be comparing 3 doses (1 mg, 2mg, and 5 mg taken twice a day) of SCH 420814 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.
Whether you will receive SCH 420814 or placebo will be decided by a process called randomization (as in the flip of a coin). Your chance of receiving the investigational drug, SCH 420814, is 75% in the first phase of the study (with a 1mg, 2mg, 5mg dose, or placebo dose arm). After 40 patients complete 12 weeks of treatment there will be an Interim Analysis which will determine the safety of the drug. If the 5 mg arm is found to be safe, then the 10 mg arm will also be added to the study. Your chance of receiving study drug (1mg, 2mg, 5mg, 10 mg, or placebo) with the 10 mg arm is 80%. If the 5 mg arm is found to be not safe, then the 10 mg arm will not be added and the 5 mg arm will also be dropped from the study. Your chance of receiving study drug (1mg, 2 mg, or placebo arm) will be 67%.
Approximately 160 subjects will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, we may add 40 new patients, for a total of 200 patients. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.
Condition | Intervention | Phase |
Parkinson Disease Movement Disorders Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases |
Drug: SCH 420814 Drug: Placebo |
Phase II |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
MedlinePlus related topics: | Brain Diseases Degenerative Nerve Diseases Movement Disorders Neurologic Diseases Parkinson's Disease |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 200 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
SCH 420814 1 mg twice daily: Experimental |
Drug: SCH 420814
1 mg twice daily
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SCH 420814 2 mg twice daily: Experimental |
Drug: SCH 420814
2 mg twice daily
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SCH 420814 5 mg twice daily: Experimental |
Drug: SCH 420814
5 mg twice daily
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Placebo twice daily: Placebo Comparator |
Drug: Placebo
twice daily
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SCH 420814 10 mg twice daily: Experimental
Following an interim analysis, a new dose group of 10 mg BID may be added after 40 subjects completed the trial.
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Drug: SCH 420814
Following an interim analysis, a new dose group of 10 mg BID may be added after 40 subjects completed the trial.
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Acceptable methods of birth control include oral or injectable hormonal contraceptive, medically prescribed IUD, and double-barrier method (eg, condom in combination with spermicide). Bilateral tubal ligation is an acceptable method of birth control for this study.
Exclusion Criteria:
Show 44 Study Locations |
Schering-Plough |
Principal Investigator: | Kenneth P Wolski, MD | Schering-Plough |
Responsible Party: | Schering-Plough ( Marc Cantillon, MD - Senior Director, Global Clinical Research, CNS ) |
Study ID Numbers: | P04501, Preladenant |
First Received: | November 30, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00406029 |
Health Authority: | United States: Food and Drug Administration |
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