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Corticosteroid

Acthar Gel for Multiple Sclerosis

N/A
Waitlist Available
Led By Michelle Fabian, 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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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

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

Side effects data

From 2021 Phase 4 trial • 55 Patients • NCT03320070
14%
Nausea
14%
Bronchitis
14%
Cough
9%
Dyspnoea
9%
Fatigue
9%
C-reactive protein increased
9%
Diarrhoea
9%
Abdominal pain
9%
Arthralgia
9%
Depression
9%
Myalgia
5%
Injection site bruising
5%
Hyperhidrosis
5%
Chest discomfort
5%
Rash
5%
Upper respiratory tract infection
5%
Weight increased
5%
Diabetes mellitus
5%
Pulmonary hypertension
5%
Pulmonary embolism
5%
Gastrooesophageal reflux disease
5%
Pneumonia
5%
Upper gastrointestinal haemorrhage
5%
Haemoglobin decreased
5%
Oedema peripheral
5%
Back pain
5%
Idiopathic pulmonary fibrosis
5%
Respiratory failure
5%
Dizziness
5%
Headache
5%
Metastatic renal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE: Acthar Gel 80 U (1 mL) [Received Acthar in DBT]
DBT: Acthar Gel 80 U (1 mL)
DBT: Placebo
OLE: Acthar Gel 80 U (1 mL) [Received Placebo in DBT]

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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
15,856 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
446 Patients Enrolled for Multiple Sclerosis
Michelle Fabian, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~1 spots leftby Nov 2025