Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01071512
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : September 6, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: Tysabri
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tysabri
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks
Period Title: Overall Study
Started 20
Completed 15
Not Completed 5
Reason Not Completed
Adverse Event             1
Development of antibodies to drug             2
positive anti-JC virus antibody test             2
Arm/Group Title Tysabri
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Includes patients that completed treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
39  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
13
  86.7%
Male
2
  13.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Caucasian
8
  53.3%
African-American
6
  40.0%
Other
1
   6.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Change in Cognitive Function Over Time
Hide Description Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.
Time Frame Baseline, 48 weeks, 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Summary statistics are based on the 15 subjects who completed treatment
Arm/Group Title Tysabri
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline -1.5  (0.9)
Week 48 -1.2  (1.0)
Week 96 -1.2  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tysabri
Comments Analysis used all available data from subjects, including those who dropped out early.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change Over Time in Retinal Nerve Fiber Layer Thickness
Hide Description Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.
Time Frame Baseline, 24, 48, 72, and 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Summary statistics are provided based on subjects completing all treatment
Arm/Group Title Tysabri
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: micrometer
Baseline 86  (13)
Week 24 85  (12)
Week 48 85  (13)
Week 72 85  (13)
Week 96 85  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tysabri
Comments Analysis used all available data
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change Over Time in Brain Parenchymal Fraction
Hide Description Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy (i.e., brain volume loss) with lower values indicating greater atrophy (possible range 0-1).
Time Frame Baseline, 48 weeks, 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Summary statistics are based on subjects completing treatment
Arm/Group Title Tysabri
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.970  (0.011)
Week 48 0.969  (0.012)
Week 96 0.971  (0.014)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tysabri
Comments Analysis used all available data
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change Over Time in Normalized Thalamic Volume
Hide Description Measured on MRI scan
Time Frame Baseline, 48 weeks, 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Summary statistics are based on subjects completing all treatment
Arm/Group Title Tysabri
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL
Baseline 13.9  (1.9)
Week 48 13.7  (2.0)
Week 96 13.7  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tysabri
Comments Analysis used all available data
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Change Over Time in Normalized Hippocampal Volume
Hide Description Measured on MRI scan
Time Frame Baseline, 48 weeks, 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Summary statistics are based on subjects completing all treatment
Arm/Group Title Tysabri
Hide Arm/Group Description:
Natalizumab 300 mg IV every 4 weeks
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL
Baseline 6.8  (0.8)
Week 48 6.7  (1.0)
Week 96 6.6  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tysabri
Comments Analysis used all available data
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 96 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tysabri
Hide Arm/Group Description Natalizumab 300 mg IV every 4 weeks
All-Cause Mortality
Tysabri
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tysabri
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tysabri
Affected / at Risk (%)
Total   1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
pruritis *  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Adil Javed
Organization: University of Chicago
Phone: 773.834.0558
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01071512     History of Changes
Other Study ID Numbers: 10-094A
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: June 15, 2017
Results First Posted: September 6, 2017
Last Update Posted: October 25, 2017