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Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00559702
First received: November 7, 2007
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to explore alternative routes of administration for natalizumab.


Condition Intervention Phase
Secondary Progressive Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis
 Drug: natalizumab
Other: standard of care
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • PK, PD [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety [ Time Frame: 13-19 months ] [ Designated as safety issue: Yes ]
  • efficacy [ Time Frame: 13-19 months ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: October 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Natalizumab IV (Subjects with secondary progressive multiple sclerosis)
 Drug: natalizumab
natalizumab
Experimental: 2
Natalizumab IM (Subjects with secondary progressive multiple sclerosis)
 Drug: natalizumab
natalizumab
Experimental: 3
Natalizumab SC (Subjects with secondary progressive multiple sclerosis)
 Drug: natalizumab
natalizumab
4
standard of care as determined by the Investigator and Treating Neurologist (Subjects with secondary progressive multiple sclerosis)
 Other: standard of care
standard of care as determined by the Investigator and Treating Neurologist
Experimental: 5
Natalizumab SC (Subjects with relapsing forms of multiple sclerosis)
 Drug: natalizumab
natalizumab
Experimental: 6
Natalizumab IV (subjects with relapsing forms of multiple sclerosis)
 Drug: natalizumab
natalizumab

Detailed Description:

This is a Phase 1 study in subjects with multiple sclerosis (MS) to evaluate the pharmacokinetic (PK) and safety profile of natalizumab doses administered by subcutaneous (SC) and intramuscular (IM) injection as potential alternative routes of delivery. An intravenous (IV) treatment group at 300 mg will be used for comparison of the PK and pharmacodynamic (PD) properties of both the SC and IM administration routes.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For arms 1,2,3,4: Diagnosis of SPMS
  • For arms 5, 6: Diagnosis of relapsing forms of MS.
  • No past history of receiving natalizumab.

Exclusion Criteria:

  • For arms 1,2,3,4 Diagnosis of primary progressive MS or relapsing-remitting MS.
  • Form arms 5,6: Diagnosis of primary progressive MS or secondary progressive MS without the occurrence of relapses.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559702

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006
Research Site
Scottsdale, Arizona, United States, 85259
United States, California
Research Site
Berkeley, California, United States, 94705
United States, Colorado
Research Site
Centennial, Colorado, United States, 80112
United States, Florida
Research Site
Maitland, Florida, United States, 32751
Research Site
Vero Beach, Florida, United States, 32960
United States, Illinois
Research Site
Peoria, Illinois, United States, 61637
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, New York
Research Site
Buffalo, New York, United States, 14203
United States, Texas
Research Site
Dallas, Texas, United States, 75214
Research Site
Round Rock, Texas, United States, 78681
United States, Virginia
Research Site
Vienna, Virginia, United States, 22182
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00559702     History of Changes
Other Study ID Numbers: 101MS102
Study First Received: November 7, 2007
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
natalizumab
multiple sclerosis
Tysabri

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
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