Trial Condition(s):

Positron-Emission Tomography, Multiple Sclerosis

Evaluation of the positron emission tomography (PET) tracer ZK 6032924 in patients with Multiple Sclerosis compared to healthy volunteers

Bayer Identifier:

13101

ClinicalTrials.gov Identifier:

NCT01031199

EudraCT Number:

2008-000981-22

Study Completed

Trial Purpose

PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers

Inclusion Criteria
Healthy volunteers for brain imaging: 
- males or females, age 20 - 55 years
- assessment of the brain MRI as "normal (age-appropriate)"
- absence of any sign of CNS disease, no co-medi
cation
Patients for brain imaging
- males or  females, age 20 - 55 years
- patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS ("drug-naïve"), or patients presenting  with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS)
- patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β
- MRI: >/= 2 T2 lesions and >/= 1 Gadolinium- (Gd-) enhancing lesion
Exclusion Criteria
Exclusion criteria for all healthy volunteers and patients:
- Pregnancy or lactation
- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
- other forms of diseases with neuroinflammatory components

Trial Summary

Enrollment Goal
16
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
F18-FEDAA1106 (BAY85-8101)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Completed
 

Trial Design