Study Completed

Positron-Emission Tomography, Multiple Sclerosis

Bayer Identifier:

13101

ClinicalTrials.gov Identifier:

NCT01031199

EudraCT Number:

2008-000981-22

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

Both

Age

20 - 55 Years

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

Trial Dates

January 2009 - December 2009

Phase

Phase 1

Could I Receive a placebo

Products

F18-FEDAA1106 (BAY85-8101)

Accepts Healthy Volunteer

Yes

Where 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.
Time Frame:
Day of study tracer administration
Safety Issue:
no
Visual analysis/description of the uptake and description of brain PET scans.
Time Frame:
Day of study tracer administration
Safety Issue:
no

Secondary Outcome

Standard Safety Parameter: Adverse Event Collection
Time Frame:
maximum time from Screening to Follow-up are 37days
Safety Issue:
yes
Standard Safety Parameter: Electrocardiogram
Time Frame:
maximum time from Screening to Follow-up are 37days
Safety Issue:
yes
Standard Safety Parameter: Safety laboratory
Time Frame:
maximum time from Screening to Follow-up are 37days
Safety Issue:
yes
Standard Safety Parameter: Vital signs
Time Frame:
maximum time from Screening to Follow-up are 37days
Safety Issue:
yes

Trial design

Open-label, non-randomized, positron emission tomography (PET) imaging study to evaluate a single dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for its diagnostic potential in either drug-naïve or specifically (IFN-beta) pretreated patients with Multiple Sclerosis (MS) with acute relapse or patients with clinically isolated syndrome (CIS), compared to healthy volunteers

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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