Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) (ACTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986960
Recruitment Status : Withdrawn (Difficult to recruit due to protocol requirements - participant burden.)
First Posted : September 30, 2009
Last Update Posted : January 5, 2021
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Brief Summary:
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: repository corticotropin injection Drug: Saline Phase 2

Detailed Description:
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study
Study Start Date : December 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Adrenocorticotropin hormone
Patients receive the hormone
Drug: repository corticotropin injection
IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
Other Name: H.P. Acthar gel

Placebo Comparator: Placebo
Patients receive placebo only
Drug: Saline
I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.

Primary Outcome Measures :
  1. To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS [ Time Frame: 1 year ]
    Effect of ACTH in MRI

Secondary Outcome Measures :
  1. To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS. [ Time Frame: 1 year ]
    Effect of ACTH on optic health

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Patient diagnosed with MS according to McDonald criteria
  • Age 18-65
  • Have a RR disease course
  • Have EDSS scores 0-5.5
  • Have a disease duration <20 years
  • Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
  • presence of a documented relapse within the last 12 months
  • or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
  • Signed informed consent
  • Normal kidney functioning (creatinine clearance >59)
  • None of the exclusion criteria

Exclusion Criteria:

  • Presence of relapse or steroid treatment within 60 days prior to study enrollment
  • Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
  • Presence of optic neuritis within less than 6 months prior to study enrollment
  • Diagnosis of osteoporosis (T score ≥2.5 SD)
  • Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
  • Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
  • History of depression while on IFNβ-1a I.M.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986960

Layout table for location information
United States, New York
University at Buffalo, Buffalo General Hospital
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Layout table for investigator information
Principal Investigator: Robert Zivadinov, MD, PhD Buffalo Neuroimaging Analysis Center
Principal Investigator: Bianca Weinstock-Guttman, MD Jacobs Neurological Institute
Layout table for additonal information
Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo Identifier: NCT00986960    
Other Study ID Numbers: NDA 08-372
NDA 08-372
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
multiple sclerosis
relapsing remitting
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs