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Monoclonal Antibodies

Group 1: Multiple Sclerosis for Multiple Sclerosis

N/A
Recruiting
Led By John DeLuca, Ph.D.
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured by change between 2 time points (baseline and six months after intervention)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this research study is to investigate the effectiveness of Tysabri on cognitive fatigue in persons with Relapsing-Remitting Multiple Sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured by change between 2 time points (baseline and six months after intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured by change between 2 time points (baseline and six months after intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain activation (BOLD signal)
Secondary study objectives
Fatigue onset
Fatigue onset (SDMT)

Side effects data

From 2012 Phase 2 & 3 trial • 106 Patients • NCT01440101
19%
Nasopharyngitis
17%
Multiple Sclerosis Relapse
6%
Insomnia
6%
Pharyngitis
4%
Eczema
2%
Basal Cell Carcinoma
2%
Asperger's Disorder
2%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Natalizumab
Open Label Natalizumab
Double-Blind Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Healthy ControlsExperimental Treatment0 Interventions
Healthy individuals who are age, gender and education matched to the MS group.
Group II: Group 1: Multiple SclerosisExperimental Treatment1 Intervention
Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
180 Previous Clinical Trials
11,034 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
1,632 Patients Enrolled for Multiple Sclerosis
St. Barnabas Medical CenterOTHER
12 Previous Clinical Trials
2,784 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
105 Patients Enrolled for Multiple Sclerosis
John DeLuca, Ph.D.Principal InvestigatorKessler Foundation
2 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
60 Patients Enrolled for Multiple Sclerosis
~1 spots leftby Dec 2024
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