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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00986960

Run by

University at Buffalo

People needed

0

Starts

2009-12-01

Expected to finish

2010-12-01

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University at Buffalo, Buffalo General Hospital — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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