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

University at Buffalo

Status and phase

Withdrawn

Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: Saline

Drug: repository corticotropin injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00986960

NDA 08-372

Details and patient eligibility

About

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.

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.