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

• Status: Withdrawn
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Treatments: Adrenocorticotropic Hormone; beta-Endorphin; Melanocyte-Stimulating Hormones

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.