Status:
COMPLETED
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secon...
Eligibility Criteria
Inclusion
- Key
- \- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)
- Key
Exclusion
- History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
- Prior natalizumab therapy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01884935
Start Date
July 1 2013
End Date
September 1 2014
Last Update
June 23 2016
Active Locations (5)
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1
Research Site
Cefalù, Italy
2
Research Site
Gallarate, Italy
3
Research Site
Milan, Italy
4
Research Site
Padua, Italy