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Peptide Vaccine
NeuroVax for Multiple Sclerosis
Phase 2
Waitlist Available
Research Sponsored by Immune Response BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Study Summary
This trial is testing a new potential MS treatment called NeuroVax against a placebo to see if it is effective in treating Secondary Progressive MS. 150 people with SPMS will be participating.
Eligible Conditions
- Multiple Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
Secondary outcome measures
Secondary measurements objectives immunologic evaluations
Side effects data
From undefined Phase 2 trial • 40 Patients • NCT0000322280%
Fatigue
60%
Injection Site Reaction
50%
Nausea
50%
Pruritus
50%
Rigors, Chills
40%
Fever
40%
Anorexia
40%
Diarrhea
40%
Headache
40%
Skin Rash/Urticaria
30%
Sweating
30%
Myalgia/Arthralgia
20%
Other PAIN
20%
Vomiting
20%
Flushing
20%
Dizziness/Lightheadedness
10%
Constipation
10%
Edema
10%
Other
10%
Stomatitis/Pharyngitis
10%
SGOT/SGPT
10%
Cough
10%
Dyspnea
10%
Hemoglobin
10%
Skin
10%
Mood
100%
80%
60%
40%
20%
0%
Study treatment Arm
Peptides Pulsed on Dendritic Cells
Peptides in GMCSF-in-adjuvant
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NeuroVaxExperimental Treatment1 Intervention
NeuroVax
Group II: IFA Incomplete Freund's AdjuvantPlacebo Group1 Intervention
Incomplete Freund's Adjuvant IFA
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Who is running the clinical trial?
Immune Response BioPharma, Inc.Lead Sponsor
4 Previous Clinical Trials
738 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
212 Patients Enrolled for Multiple Sclerosis
croAMBIG
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
200 Patients Enrolled for Multiple Sclerosis
Richard M Bartholomew, Ph.DStudy DirectorImmune Response BioPharma, Inc.
2 Previous Clinical Trials
212 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
212 Patients Enrolled for Multiple Sclerosis
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