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

Tracking Information
First Received Date ^ICMJE	November 7, 2007
Last Updated Date	November 1, 2012
Start Date ^ICMJE	October 2007
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 10, 2007)	PK, PD [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: November 14, 2007)	PK, PD [ Time Frame: 32 weeks ]
Change History	Complete list of historical versions of study NCT00559702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 29, 2008)	safety [ Time Frame: 13-19 months ] [ Designated as safety issue: Yes ] efficacy [ Time Frame: 13-19 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: November 14, 2007)	safety [ Time Frame: 32 weeks ] efficacy [ Time Frame: 32 weeks ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
Official Title ^ICMJE	A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis
Brief Summary	The purpose of this study is to explore alternative routes of administration for 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Secondary Progressive Multiple Sclerosis Relapsing Forms of Multiple Sclerosis
Intervention ^ICMJE	Drug: natalizumab natalizumab Other: standard of care standard of care as determined by the Investigator and Treating Neurologist
Study Arm (s)	Experimental: 1 Natalizumab IV (Subjects with secondary progressive multiple sclerosis) Intervention: Drug: natalizumab Experimental: 2 Natalizumab IM (Subjects with secondary progressive multiple sclerosis) Intervention: Drug: natalizumab Experimental: 3 Natalizumab SC (Subjects with secondary progressive multiple sclerosis) Intervention: Drug: natalizumab 4 standard of care as determined by the Investigator and Treating Neurologist (Subjects with secondary progressive multiple sclerosis) Intervention: Other: standard of care Experimental: 5 Natalizumab SC (Subjects with relapsing forms of multiple sclerosis) Intervention: Drug: natalizumab Experimental: 6 Natalizumab IV (subjects with relapsing forms of multiple sclerosis) Intervention: Drug: natalizumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	76
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00559702
Other Study ID Numbers ^ICMJE	101MS102
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Elan Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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