Title
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
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
Phase
Phase 2Lead Sponsor
State University of New York, BuffaloStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Multiple SclerosisIntervention/Treatment
corticotropin sodium chloride ...Study Participants
0The 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.
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.
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
I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
Patients receive the hormone
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.
