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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01031199




Registration number
NCT01031199
Ethics application status
Date submitted
11/12/2009
Date registered
14/12/2009
Date last updated
2/04/2014

Titles & IDs
Public title
Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
2008-000981-22
Secondary ID [2] 0 0
13101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positron-Emission Tomography 0 0
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - F-18 FEDAA1106 (BAY85-8101)
Treatment: Drugs - F-18 FEDAA1106 (BAY85-8101)

Experimental: Arm 1 -

Experimental: Arm 2 -


Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Standard quantification variables derived from 3D PET imaging and brain modeling.
Timepoint [1] 0 0
Day of study tracer administration
Primary outcome [2] 0 0
Visual analysis/description of the uptake and description of brain PET scans.
Timepoint [2] 0 0
Day of study tracer administration
Secondary outcome [1] 0 0
Standard Safety Parameter: Adverse Event Collection
Timepoint [1] 0 0
maximum time from Screening to Follow-up are 37days
Secondary outcome [2] 0 0
Standard Safety Parameter: Electrocardiogram
Timepoint [2] 0 0
maximum time from Screening to Follow-up are 37days
Secondary outcome [3] 0 0
Standard Safety Parameter: Safety laboratory
Timepoint [3] 0 0
maximum time from Screening to Follow-up are 37days
Secondary outcome [4] 0 0
Standard Safety Parameter: Vital signs
Timepoint [4] 0 0
maximum time from Screening to Follow-up are 37days

Eligibility
Key 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
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
Trial website
https://clinicaltrials.gov/study/NCT01031199
Trial related presentations / publications
Takano A, Piehl F, Hillert J, Varrone A, Nag S, Gulyas B, Stenkrona P, Villemagne VL, Rowe CC, Macdonell R, Tawil NA, Kucinski T, Zimmermann T, Schultze-Mosgau M, Thiele A, Hoffmann A, Halldin C. In vivo TSPO imaging in patients with multiple sclerosis: a brain PET study with [18F]FEDAA1106. EJNMMI Res. 2013 Apr 24;3(1):30. doi: 10.1186/2191-219X-3-30.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01031199