Pulse ACTH vs. MP for MS

• ClinicalTrials.gov Identifier: NCT01049451
• Recruitment Status: Completed
• First Posted: January 14, 2010
• Last Update Posted: April 19, 2017
• Sponsor: University of Southern California
• Information provided by (Responsible Party): Regina Berkovich, University of Southern California

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: ACTH; Drug: Methylprednisolone	Phase 1

Detailed Description:

Please see the final manuscript

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)
• Study Start Date: November 2009
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACTH IM monthly; 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; 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.; Other Name: Acthar Gel
Active Comparator: MP IV monthly; Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months.	Drug: Methylprednisolone; Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months; Other Name: Solumedrol

Outcome Measures

Primary Outcome Measures :

1. Annualized Relapse Rate [ Time Frame: 15 months study: 12 months treatment and 3 months follow up ]

Secondary Outcome Measures :

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. [ Time Frame: 15 months: 12 months treatmen and 3 months follow up ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Clinically definite multiple sclerosis defined by McDonald Criteria.
2. Between 18-65 years of age.
3. 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).
4. 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.
5. 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.
6. EDSS (Expanded Disability Status Scale) score of 3.0 - 6.5
7. Currently on one of the approved beta-interferon drugs (Avonex, Betaseron, or Rebif) for a minimum of 6 months.

Exclusion Criteria:

1. 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.
2. 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.
3. Subject has a history of drug or alcohol abuse within the past year.
4. Subject had corticosteroid treatment within last 90 days.
5. Subject started new medication within last 30 days.
6. Subject is on Tysabri treatment presently or within 6 months of screening.
7. Subject is on Novantrone, Cellcept, Rituxan or other chemotherapeutic treatment presently or within 6 months of screening.
8. Subject is a participant in another research project.
9. Subject has contraindications for either ACTH or MP administration.

Contacts and Locations

Locations

United States, California

USC MS Center

Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

Investigators

• Principal Investigator: Regina R Berkovich, MD, PhD; University of Southern California

More Information

• Responsible Party: Regina Berkovich, Assistant Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT01049451
• Other Study ID Numbers: ACTH-001; IND 104,973 ( Registry Identifier: IND 104,973 )
• First Posted: January 14, 2010
• Last Update Posted: April 19, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Regina Berkovich, University of Southern California:

Multiple Sclerosis; ACTH; Steroids

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents