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

Multiple Sclerosis Clinical Trial

— ACTH  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00986960
• Other study ID #: NDA 08-372
• Secondary ID: NDA 08-372
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2020
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 IFNß-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 IFNß-1a I.M.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	University at Buffalo, Buffalo General Hospital	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the effect of add-on pulsed IM ACTH vs. placebo to IFNß-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS	Effect of ACTH in MRI	1 year
Secondary	To define the effect of add-on pulsed IM ACTH vs. placebo to IFNß-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.	Effect of ACTH on optic health	1 year