Pulse ACTH vs. MP for MS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01049451
• Date of registration: 13/01/2010
• Prospective Registration: No
• Primary sponsor: University of Southern California
• Public title: Pulse ACTH vs. MP for MS
• Scientific 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)
• Date of first enrolment: November 2009
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01049451
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Regina R Berkovich, MD, PhD
• Affiliation: University of Southern California

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: ACTH

Drug: Methylprednisolone

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

IND 104,973

ACTH-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors