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Corticosteroid

ACTH for Multiple Sclerosis

Phase 2

Waitlist Available

Led By Adam F Carpenter, MD

Research Sponsored by University of Minnesota

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 month 36

Awards & highlights

Study Summary

This trial will test whether a monthly injection of ACTH gel is safe and effective in slowing the progression of multiple sclerosis.

Eligible Conditions

Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients exhibiting a 20% worsening in T25FW at 36 months

Secondary outcome measures

Safety and tolerability of ACTH

Other outcome measures

Retinal nerve fiber layer thickness

Slowed progression of sustained cognitive disability

Side effects data

From 2018 Phase 3 trial • 31 Patients • NCT02132195

20%

Hospitalization for renal disease relapse affecting multiple systems

13%

Behavioral changes

13%

Sleep disturbances

Increase in blood pressure

Swelling, redness, rash at injection site

100%

80%

60%

40%

20%

Study treatment Arm

Adrenocorticotropic Hormone (ACTH)

No Treatment

Rescue Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ACTHExperimental Treatment1 Intervention

ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month

Group II: PlaceboPlacebo Group1 Intervention

Placebo subcutaneous injections administered on 3 consecutive days per month

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ACTH

2013

Completed Phase 4

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,377 Previous Clinical Trials

1,588,237 Total Patients Enrolled

5 Trials studying Multiple Sclerosis

878 Patients Enrolled for Multiple Sclerosis

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,169 Total Patients Enrolled

10 Trials studying Multiple Sclerosis

397 Patients Enrolled for Multiple Sclerosis

Adam F Carpenter, MDPrincipal InvestigatorUniversity of Minnesota

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

40 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.

What can be inferred about the security of administering ACTH?

"After careful consideration, our team at Power assigned ACTH a safety ranking of 2. This is because the Phase 2 trial provides some evidence that it may be safe but no clear indication of efficacy yet."

Answered by AI

Are any vacancies available for participants in this experiment?

"Information sourced from clinicaltrials.gov suggests that this trial has ceased looking for potential candidates as its most recent edit occurred on August 2nd, 2022. While the experiment is no longer enrolling subjects, there are 558 other medical trials actively seeking participants at present."

Answered by AI

What is the total number of participants in this clinical experiment?

"Unfortunately, this clinical trial has concluded its recruitment phase. It was first posted on October 1st 2013 and last updated August 2nd 2022. If you are still searching for studies to join, there are currently 549 trials recruiting patients with multiple sclerosis and 9 that involve the hormone ACTH."

Answered by AI

What conditions have been treated with Adrenocorticotropic hormone (ACTH)?

"Acute coryza is most frequently treated with the administration of ACTH. This medication has proven effective in treating a variety of other diseases including juvenile rheumatoid arthritis, optic neuritis, and dermatomyositis."

Answered by AI

Are there other existing experiments that have delved into the use of ACTH?

"The first research into ACTH was conducted at Princess Margaret Hospital for Children in 2004, and since then 18356 studies have been finalized. Presently, nine trials are actively recruiting participants; a significant portion of which originate from Fargo, North dakota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ACTH in Progressive Forms of MS

2014. "ACTH in Progressive Forms of MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01950234.