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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00559702
Date of registration: 07/11/2007
Prospective Registration: Yes
Primary sponsor: Biogen Idec
Public title: Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
Scientific 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
Date of first enrolment: October 2007
Target sample size: 76
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00559702
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Biogen Idec
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- For arms 1,2,3 and 4: Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS)

- For arms 5 and 6: Diagnosis of relapsing forms of Multiple Sclerosis (MS).

- No past history of receiving natalizumab.

Key Exclusion Criteria:

- For arms 1,2,3 and 4 Diagnosis of primary progressive MS or relapsing-remitting MS.

- Form arms 5 and 6: Diagnosis of primary progressive MS or secondary progressive MS
without the occurrence of relapses.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Intervention(s)
Drug: natalizumab
Other: standard of care
Primary Outcome(s)
a4-integrin saturation [Time Frame: Pre-dose, 4, 24 and 72 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Apparent Clearance of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Apparent volume of distribution of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Area under the curve extrapolated to infinity (AUC0-8) of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Area under the curve to the last measurable concentration (AUC0-last) of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Half-life of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Maximum observed concentration (Cmax) of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Time to maximum observed concentration (Tmax) of natalizumab [Time Frame: Pre-dose, 4, 24, 48, 72 and 96 hours post-dose and Days 7, 14, 21, 28, 35, 42 and 56]
Secondary Outcome(s)
Change form Baseline in Multiple Sclerosis Functional Composite Scale (MFSC) [Time Frame: Baseline, Weeks 8, 20, and 32]
Change from Baseline in expanded disability status scale (EDSS) [Time Frame: Baseline, Weeks 8, 20, and 32]
Change from Baseline in Symbol Digit Modalities Test (SDMT) [Time Frame: Baseline, Weeks 8, 20, and 32]
Change from Baseline in visual analog scale (VAS) [Time Frame: Baseline, Weeks 8, 20, and 32]
Change from Baseline in visual function test [Time Frame: Baseline, Weeks 8, 20, and 32]
Diffusion tensor imaging (DTI) [Time Frame: Baseline and Week 32]
Injection site pain assessment [Time Frame: Pre-dose, 5 and 15 minutes and 24 hours post-dose]
Number of new gadolinium-enhanced lesions [Time Frame: Baseline and Week 32]
Number of new or newly enlarging T2 hyperintense lesions [Time Frame: Baseline and Week 32]
Number of new T1 hypointense lesions [Time Frame: Baseline and Week 32]
Number of participants with abnormal laboratory test results [Time Frame: 13-19 months]
Number of participants with abnormalities in vital signs [Time Frame: 13-19 months]
Number of Participants with adverse events [Time Frame: 13-19 months]
Number of participants with changes in the physical examination [Time Frame: 13-19 months]
Number of participants with natalizumab antibodies [Time Frame: Days 28, 42, 56, Weeks 24 and 32]
Percent change in magnetization transfer ratio (MTR) [Time Frame: Baseline and Week 32]
Whole brain atrophy [Time Frame: Baseline and Week 32]
Secondary ID(s)
101MS102
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Elan Pharmaceuticals
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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