Pulse ACTH vs. MP for MS

NCT ID: NCT01049451

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-07-31

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.

Detailed Description

Please see the final manuscript

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ACTH

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Methylprednisolone

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

Intervention Type: DRUG

Other Intervention Names

Acthar Gel; Solumedrol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Regina Berkovich

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Regina R Berkovich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC MS Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IND 104,973

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTH-001

Identifier Type: -

Identifier Source: org_study_id