Recruiting

Acthar Gel

Sponsor:

Aaron Miller

Code:

NCT01900093

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Acthar Gel

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Study ID

NCT01900093

Start date

Jul, 2013

Status verified date

Sep, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 18-65
  • EDSS of 2.0 - 7.5 (inclusive)
  • Sustained a significant MS exacerbation affecting vision, brainstem, motor, or cerebellar function AND were initially treated with a 5 day course of IVMP within 10 days of the onset of symptoms.
  • Failed to make adequate improvement and must initiate Acthar Gel therapy within two weeks (+/- 72 hours) after the first day of 5 treatments with 1000 mg IVMP, as judged by their treating neurologist.
  • Must be able to comply with the requirements of the protocol as determined by the investigator.
  • Ability to understand the purpose and risks of the study and provide signed and date informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

Exclusion Criteria:

  • Patients whose relapse consists of pure sensory or bowel/bladder symptoms
  • History of ACTHAR gel use or other forms of ACTH with failure to improve or with occurrence of significant adverse experiences.
  • Diagnosis of scleroderma, systemic fungal infections, ocular herpes simplex, congestive heart failure, and/or uncontrolled hypertension, and/or any clinically relevant medical disease that would put the patient at risk by participating in the study
  • Persistent significant or severe infection
  • Recent history of drug or alcohol abuse
  • Concomitant use or prior use in the preceding 6 months of any investigational drug.
  • Pregnant or nursing
  • Recent surgery (up to the investigator's discretion what constitutes recent)
  • History of, or the presence of, a peptic ulcer
  • Known sensitivity to proteins of porcine origin
  • Received a live or live attenuated vaccine in the last 30 days before baseline

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acthar Gel

80 units of subcutaneous Acthar Gel therapy daily

Interventions

Acthar Gel

80 units of subcutaneous Acthar Gel therapy daily

Primary outcome measure

  • Improvement in Functional System Score appropriate to the Targeted Neurological Deficit [ Time Frame: at one week ]

Central Contacts and Locations

Central contacts

Tarah Herrmann

212-241-4264tarah.gustafson@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Aaron Miller, MD

More Information

Sponsor

Aaron Miller

Last update posted

Sep 6, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aaron Miller on 2017-09-06.