Back to resultsEffect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) (ACTH)
Primary Purpose
Multiple Sclerosis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
repository corticotropin injection
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, relapsing remitting, RRMS
Eligibility 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.
Sites / Locations
- University at Buffalo, Buffalo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Adrenocorticotropin hormone
Placebo
Arm Description
Patients receive the hormone
Patients receive placebo only
Outcomes
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
Effect of ACTH in MRI
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.
Effect of ACTH on optic health
Full Information
NCT ID
NCT00986960
First Posted
September 29, 2009
Last Updated
December 30, 2020
Sponsor
University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT00986960
Brief Title
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
Acronym
ACTH
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 Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Difficult to recruit due to protocol requirements - participant burden.
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, relapsing remitting, RRMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adrenocorticotropin hormone
Arm Type
Active Comparator
Arm Description
Patients receive the hormone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo only
Intervention Type
Drug
Intervention Name(s)
repository corticotropin injection
Other Intervention Name(s)
H.P. Acthar gel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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 Measure Information:
Title
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
Description
Effect of ACTH in MRI
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
Effect of ACTH on optic health
Time Frame
1 year
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Zivadinov, MD, PhD
Organizational Affiliation
Buffalo Neuroimaging Analysis Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bianca Weinstock-Guttman, MD
Organizational Affiliation
Jacobs Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo, Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
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