Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

Phase 1

Completed

• Conditions: Positron-Emission Tomography; Multiple Sclerosis
• Interventions: Drug: F-18 FEDAA1106 (BAY85-8101)

• Registration Number: NCT01031199
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	F-18 FEDAA1106 (BAY85-8101)	-
Arm 1	F-18 FEDAA1106 (BAY85-8101)	-

Primary Outcome Measures

Name	Time	Method
Standard quantification variables derived from 3D PET imaging and brain modeling.	Day of study tracer administration
Visual analysis/description of the uptake and description of brain PET scans.	Day of study tracer administration

Secondary Outcome Measures

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