Multiple Sclerosis Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Study ID:

NCT00986960

Recruitment Status:

Withdrawn

Sponsor:

University at Buffalo

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University at Buffalo, Buffalo General Hospital
Buffalo New York, 14203, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Study ID:

NCT00986960

Recruitment Status:

Withdrawn

Sponsor:


University at Buffalo

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider