Clinical trial NCT00986960: Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
relapsing remitting
RRMS
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Buffalo General Hospital
state: New York
Study officials:
affiliation: Buffalo Neuroimaging Analysis Center
name: Robert Zivadinov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacobs Neurological Institute
name: Bianca Weinstock-Guttman, MD
role: PRINCIPAL_INVESTIGATOR
References: