Pulse ACTH vs. MP for MS

NCT01049451 | Completed Phase 1 DMC

• 2 other identifiers: ACTH-001IND 104,973
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determine whether ACTH, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell environment.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; ACTH; Steroids

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate

  15 months study: 12 months treatment and 3 months follow up

Secondary Outcomes (1)

• Multiple Sclerosis Functional Composite (MSFC), Expanded Disability Status Scale score (EDSS) and Multiple Sclerosis Quality of Life (MSQOL), peripheral blood lymphocytes measure for regulatory immune activities.

  15 months: 12 months treatmen and 3 months follow up

Study Arms (2)

ACTH IM monthly

EXPERIMENTAL

Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.

Drug: ACTH

MP IV monthly

ACTIVE COMPARATOR

Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months.

Drug: Methylprednisolone

Interventions

ACTH DRUG

Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.

Also known as: Acthar Gel

ACTH IM monthly

Methylprednisolone DRUG

Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months

Also known as: Solumedrol

MP IV monthly

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically definite multiple sclerosis defined by McDonald Criteria.
• Between 18-65 years of age.
• Subject must able to understand and sign the IRB- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol, including self-administration of study drug (if assigned to the ACTH arm).
• Subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
• Subjects must have at least one MS relapse within last year and/or at least one new T2 or Gadolinium-enhanced lesion on MRI while on stable interferon therapy.
• EDSS (Expanded Disability Status Scale) score of 3.0 - 6.5
• Currently on one of the approved beta-interferon drugs (Avonex, Betaseron, or Rebif) for a minimum of 6 months.

You may not qualify if:

• Women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years post menopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
• Uncontrolled hypertension, clinically significant cardiac arrhythmias, gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of renal failure, psychiatric disorders or any other clinically significant general health conditions that may interfere with the trial participation.
• Subject has a history of drug or alcohol abuse within the past year.
• Subject had corticosteroid treatment within last 90 days.
• Subject started new medication within last 30 days.
• Subject is on Tysabri treatment presently or within 6 months of screening.
• Subject is on Novantrone, Cellcept, Rituxan or other chemotherapeutic treatment presently or within 6 months of screening.
• Subject is a participant in another research project.
• Subject has contraindications for either ACTH or MP administration.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC MS Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Adrenocorticotropic Hormone; Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Regina R Berkovich, MD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)