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

This study has been terminated.
(Difficult to recruit due to protocol requirements - participant burden.)
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT00986960
First received: September 29, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: repository corticotropin injection
Drug: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    None. Study did not initiate recruitment or data collection.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adrenocorticotropin 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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986960

Locations
United States, New York
University at Buffalo, Buffalo General Hospital
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Investigators
Principal Investigator: Robert Zivadinov, MD, PhD Buffalo Neuroimaging Analysis Center
Principal Investigator: Bianca Weinstock-Guttman, MD Jacobs Neurological Institute
  More Information

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT00986960     History of Changes
Other Study ID Numbers: NDA 08-372, NDA 08-372
Study First Received: September 29, 2009
Results First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University at Buffalo:
multiple sclerosis
relapsing remitting
RRMS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Adrenocorticotropic Hormone
Beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014