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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Positron-Emission Tomography Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

F-18 FEDAA1106 (BAY85-8101)

Intervention Type DRUG

MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET

Arm 2

Group Type EXPERIMENTAL

F-18 FEDAA1106 (BAY85-8101)

Intervention Type DRUG

Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET

Interventions

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F-18 FEDAA1106 (BAY85-8101)

MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET

Intervention Type DRUG

F-18 FEDAA1106 (BAY85-8101)

Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes