Trial record 6 of 25 for:    Tysabri | Open Studies

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01884935
First received: June 20, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

The primary objective of the study is to determine the pharmacokinetic profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the PD profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Biological: Natalizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • predose (trough) concentrations from multiple dosing (Cpredose) [ Time Frame: Up to week 16 ] [ Designated as safety issue: No ]
  • maximum plasma concentration (Cmax) [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • time to maximum plasma concentration (Tmax) [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • area under the plasma concentration curve from time of first dose to infinity (AUCinf) [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • apparent clearance (Cl/F) [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • volume of distribution [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • elimination half-life (t1/2) [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the average and minimum saturation values of α4 integrin over the dosing interval [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs [ Time Frame: Up to Week 16 ] [ Designated as safety issue: Yes ]
  • the presence of anti-natalizumab antibodies [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab
300 mg of Natalizumab intravenously (IV) every 4 weeks
Biological: Natalizumab
300mg Intravenous administration every 4 weeks
Other Name: Tysabri

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Other inclusion criteria may apply

Exclusion Criteria:

  • 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.
  • Other exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884935

Contacts
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com

Locations
Italy
Research Site Recruiting
Cefalu, Italy
Research Site Recruiting
Gallarate, Italy
Research Site Recruiting
Milan, Italy
Research Site Not yet recruiting
Padua, Italy
Research Site Recruiting
Rome, Italy
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01884935     History of Changes
Other Study ID Numbers: 101MS328, 2012-005082-13
Study First Received: June 20, 2013
Last Updated: November 1, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Biogen Idec:
Pediatric

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 July 31, 2014