Back to resultsPulse ACTH vs. MP for MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACTH
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, ACTH, Steroids
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- USC MS Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACTH IM monthly
MP IV monthly
Arm Description
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.
Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months.
Outcomes
Primary Outcome Measures
Annualized Relapse Rate
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01049451
First Posted
January 13, 2010
Last Updated
April 17, 2017
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01049451
Brief Title
Pulse ACTH vs. MP for MS
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Please see the final manuscript
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, ACTH, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACTH IM monthly
Arm Type
Experimental
Arm Description
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.
Arm Title
MP IV monthly
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
ACTH
Other Intervention Name(s)
Acthar Gel
Intervention Description
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
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Solumedrol
Intervention Description
Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months
Primary Outcome Measure Information:
Title
Annualized Relapse Rate
Time Frame
15 months study: 12 months treatment and 3 months follow up
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina R Berkovich, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC MS Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pulse ACTH vs. MP for MS
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