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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01031199
First received: December 11, 2009
Last updated: March 31, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Positron-Emission Tomography
Multiple Sclerosis
 Drug: F-18 FEDAA1106 (BAY85-8101)
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Standard quantification variables derived from 3D PET imaging and brain modeling. [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]
  • Visual analysis/description of the uptake and description of brain PET scans. [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standard Safety Parameter: Adverse Event Collection [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
  • Standard Safety Parameter: Electrocardiogram [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
  • Standard Safety Parameter: Safety laboratory [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
  • Standard Safety Parameter: Vital signs [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Experimental: Arm 2 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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031199

Locations
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Sweden
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01031199     History of Changes
Other Study ID Numbers: 13101, 2008-000981-22
Study First Received: December 11, 2009
Last Updated: March 31, 2013
Health Authority: Sweden: Medical Products Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayer:
Multiple sclerosis
Diagnostic imaging
Neuroinflammation
PET diagnosis
PET tracer

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013