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

NCT ID: NCT00986960

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Adrenocorticotropin hormone

Patients receive the hormone

Group Type: ACTIVE_COMPARATOR

repository corticotropin injection

Intervention Type: DRUG

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

Placebo

Patients receive placebo only

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.

Interventions

repository corticotropin injection

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

Intervention Type: DRUG

Saline

I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.

Intervention Type: DRUG

Other Intervention Names

H.P. Acthar gel

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)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Robert Zivadinov, MD, PhD

Director, Buffalo Neuroimaging Analysis Center, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Zivadinov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Buffalo Neuroimaging Analysis Center

Bianca Weinstock-Guttman, MD

Role: PRINCIPAL_INVESTIGATOR

Jacobs Neurological Institute

Locations

University at Buffalo, Buffalo General Hospital

Buffalo, New York, United States

Countries

United States

Other Identifiers

NDA 08-372

Identifier Type: -

Identifier Source: secondary_id

NDA 08-372

Identifier Type: -

Identifier Source: org_study_id