check_circleStudy 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
  • 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 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
January 2009 - December 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
F18-FEDAA1106 (BAY85-8101)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 administration
    enhanced_encryption
    Safety Issue:
    no
  • Visual analysis/description of the uptake and description of brain PET scans.
    date_rangeTime Frame:
    Day of study tracer administration
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Standard Safety Parameter: Adverse Event Collection
    date_rangeTime Frame:
    maximum time from Screening to Follow-up are 37days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Parameter: Electrocardiogram
    date_rangeTime Frame:
    maximum time from Screening to Follow-up are 37days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Parameter: Safety laboratory
    date_rangeTime Frame:
    maximum time from Screening to Follow-up are 37days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Parameter: Vital signs
    date_rangeTime Frame:
    maximum time from Screening to Follow-up are 37days
    enhanced_encryption
    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
2

Additional Information

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