check_circleStudy Completed
Positron-Emission Tomography, Multiple Sclerosis
Bayer Identifier:
13101
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluation of the positron emission tomography (PET) tracer ZK 6032924 in patients with Multiple Sclerosis compared to healthy volunteers
Trial purpose
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
Key Participants Requirements
Sex
BothAge
20 - 55 YearsTrial summary
Enrollment Goal
16Trial Dates
January 2009 - December 2009Phase
Phase 1Could I Receive a placebo
NoProducts
F18-FEDAA1106 (BAY85-8101)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Stockholm, 171 76, Sweden | |
Completed | Heidelberg, 3084, Australia |
Primary Outcome
- Standard quantification variables derived from 3D PET imaging and brain modeling.date_rangeTime Frame:Day of study tracer administrationenhanced_encryptionnoSafety Issue:
- Visual analysis/description of the uptake and description of brain PET scans.date_rangeTime Frame:Day of study tracer administrationenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Standard Safety Parameter: Adverse Event Collectiondate_rangeTime Frame:maximum time from Screening to Follow-up are 37daysenhanced_encryptionyesSafety Issue:
- Standard Safety Parameter: Electrocardiogramdate_rangeTime Frame:maximum time from Screening to Follow-up are 37daysenhanced_encryptionyesSafety Issue:
- Standard Safety Parameter: Safety laboratorydate_rangeTime Frame:maximum time from Screening to Follow-up are 37daysenhanced_encryptionyesSafety Issue:
- Standard Safety Parameter: Vital signsdate_rangeTime Frame:maximum time from Screening to Follow-up are 37daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2