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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031199
• Other study ID #: 13101
• Secondary ID: 2008-000981-22
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2009
• Last updated: April 1, 2014
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 ß

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Sclerosis
• Positron-Emission Tomography
• Sclerosis

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard quantification variables derived from 3D PET imaging and brain modeling.		Day of study tracer administration	No
Primary	Visual analysis/description of the uptake and description of brain PET scans.		Day of study tracer administration	No
Secondary	Standard Safety Parameter: Adverse Event Collection		maximum time from Screening to Follow-up are 37days	Yes
Secondary	Standard Safety Parameter: Electrocardiogram		maximum time from Screening to Follow-up are 37days	Yes
Secondary	Standard Safety Parameter: Safety laboratory		maximum time from Screening to Follow-up are 37days	Yes
Secondary	Standard Safety Parameter: Vital signs		maximum time from Screening to Follow-up are 37days	Yes

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