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

Phase 2

Withdrawn

• Conditions: Multiple Sclerosis
• Interventions: Drug: Saline; Drug: repository corticotropin injection

• Registration Number: NCT00986960
• Lead Sponsor: University at Buffalo

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.

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-12
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Patients receive placebo only
Adrenocorticotropin hormone	repository corticotropin injection	Patients receive the hormone

Primary Outcome Measures

Name	Time	Method
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	1 year	Effect of ACTH in MRI

Secondary Outcome Measures

Name	Time	Method
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.	1 year	Effect of ACTH on optic health

Trial Locations

Locations (1)

University at Buffalo, Buffalo General Hospital; 🇺🇸 Buffalo, New York, United States