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Trial NCT00296192

Resource URI: http://static.linkedct.org/resource/trials/NCT00296192
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/58015>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60025>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60026>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60028>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60029>
linkedct:brief_title Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
linkedct:condition <http://static.linkedct.org/resource/condition/9688>
linkedct:criteria Inclusion Criteria: - Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration - At least 30 years of age Exclusion Criteria: - Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions
linkedct:description The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 30 Years
linkedct:end_date June 2006
linkedct:enrollment 82 (xsd:int)
linkedct:firstreceived_date February 22, 2006
linkedct:has_dmc No
linkedct:id NCT00296192
linkedct:intervention <http://static.linkedct.org/resource/intervention/105668>
linkedct:intervention <http://static.linkedct.org/resource/intervention/111499>
rdfs:label Trial NCT00296192
linkedct:lastchanged_date June 16, 2009
linkedct:lead_sponsor_agency UCB, Inc.
linkedct:nct_id NCT00296192
linkedct:number_of_arms 5 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease
linkedct:org_study_id SP873
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59546>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/1106>
linkedct:oversight <http://static.linkedct.org/resource/oversight/122>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2484>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2859>
foaf:page <http://clinicaltrials.gov/show/NCT00296192>
linkedct:phase Phase 2
linkedct:primary_completion_date June 2006
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/33315>
linkedct:secondary_id EudraCT: 2005-004290-19
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/115619>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/130660>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/1414>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/24090>
linkedct:source UCB, Inc.
linkedct:start_date February 2006
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme. Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores. The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006
rdf:type linkedct:trials
linkedct:verification_date June 2009