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Corticosteroid

Acthar Gel for Multiple Sclerosis

N/A
Waitlist Available
Led By Emily S Riser, MD
Research Sponsored by Tanner Foundation for Multiple Sclerosis
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 within 1 month post initiation of treatment with acthar gel
Awards & highlights

Study Summary

This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month post initiation of treatment with acthar gel
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month post initiation of treatment with acthar gel for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life

Side effects data

From 2021 Phase 4 trial • 55 Patients • NCT03320070
22%
Diabetes mellitus
19%
Upper respiratory tract infection
15%
Fatigue
15%
Headache
11%
Oedema peripheral
11%
Sarcoidosis
11%
Contusion
11%
Dizziness
7%
Injection site bruising
7%
Dry eye
7%
Ocular hyperaemia
7%
Diarrhoea
7%
Nausea
7%
Injection site swelling
7%
Peripheral swelling
7%
Oral candidiasis
7%
Urinary tract infection
7%
Hyperglycaemia
7%
Hyperlipidaemia
7%
Hypophosphataemia
7%
Obesity
7%
Cough
7%
Hyperhidrosis
7%
Hypertension
7%
Arthralgia
7%
Depression
7%
Polyuria
7%
Weight increased
4%
Increased appetite
4%
Asthma
4%
Abdominal pain
4%
Gastrooesophageal reflux disease
4%
Bronchitis
4%
C-reactive protein increased
4%
Rash macular
4%
Dyspnoea
4%
Uveitis
4%
Cholelithiasis
4%
Influenza
4%
Skin lesion
4%
Myalgia
4%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
DBT: Acthar Gel 80 U (1 mL)
OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT]
DBT: Placebo
OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acthar GelExperimental Treatment1 Intervention
Acthar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticotropin
FDA approved

Find a Location

Who is running the clinical trial?

iReportoire IncUNKNOWN
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,208 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
436 Patients Enrolled for Multiple Sclerosis
Tanner Foundation for Multiple SclerosisLead Sponsor
2 Previous Clinical Trials
923 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
379 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comprehensive Analysis of Relapse in Multiple Sclerosis
2013. "Comprehensive Analysis of Relapse in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01906684.
All > Primary Progressive Multiple Sclerosis
~2 spots leftby May 2025
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