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Corticosteroid

Acthar Gel for Multiple Sclerosis

N/A
Waitlist Available
Led By Sylvia Klineova, MD
Research Sponsored by Aaron Miller
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 baseline and at 1 week
Awards & highlights

Study Summary

Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to evaluate the response to ACTHAR gel therapy in patients who have failed to make a satisfactory recovery after treatment with high dose IVMP. Documentation of the clinical course as well as any adverse events related to IVMP use will be made. The investigators propose to study the potential benefit of a 14-day course (the dose historically used since the landmark clinical trial of Rose et al1) of subcutaneous ACTHAR gel in 10 patients who have demonstrated inadequate improvement after a course of IVMP, 1000 mg daily, for 5 treatments (over a maximum of 8 days). These would be patients for whom PLEX would be considered as a treatment possibility. The primary outcome measure will be improvement in the targeted neurological deficit, as measured on the appropriate functional system score (FSS) of the EDSS.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at one week
This trial's timeline: 3 weeks for screening, Varies for treatment, and at one week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Functional System Score appropriate to the Targeted Neurological Deficit
Secondary outcome measures
Improvement in Expanded Disability Status Scale

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: Placebo
DBT: Acthar Gel 80 U (1 mL)
OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT]
OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acthar GelExperimental Treatment1 Intervention
80 units of subcutaneous Acthar Gel therapy daily
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?

Aaron MillerLead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,218 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
446 Patients Enrolled for Multiple Sclerosis
Sylvia Klineova, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025