Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.

Key facts

Study ID: NCT00947895
Run by: Neurologique Foundation, Inc.
People needed: 30
Starts: 2009-10-01
Expected to finish: 2011-01-01
Last updated by the study team: 2016-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

male or female
females of childbearing potential must:
have negative pregnancy tests prior to entry into the Double-blind Treatment Phase
agree to use adequate contraception during the treatment.
females who are either post-menopausal for 12 months prior to randomization or surgically sterile (if documented), may be included without above requirements
≥ 18 years of age
sign written informed consent prior to participating in the study (Appendix 1)
willing and able to comply with trial requirements, including visit schedule and completion of scales
diagnosis of multiple sclerosis by 2005 revised McDonald criteria (Appendix 3)
an Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
currently taking a stable dose of an injectable MS disease modifying agent for the preceding 6 months or greater prior to the study-entry relapse
in the opinion of their treating physician should undergo a 3 - 5 day course of IV methylprednisolone

You may not qualify if…

a manifestation of MS other than relapsing
initial IV MP greater than 14 days after from start of presenting relapse
a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
a contraindication to steroid therapy, e.g., peptic ulcer, psychotic states or severe hypertension
sensitivity to proteins of porcine origin
a known or 'new' diagnosis of severe depression as defined by a score greater than 30 on the Beck Depression Inventory (BDI)
a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication
treatment with Natalizumab in the past 6 months
active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
have received total lymphoid irradiation or bone marrow transplantation
have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Pre-Randomization Phase
any medically unstable condition, as assessed by the primary treating physician
any of the following neurologic/psychiatric disorders:
history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol
any of the following abnormal laboratory values:
serum creatinine greater than 1.7 mg/dL (150 μmol/L)
white blood cell (WBC) count <3,500/mm3 (<3.5 X 109 / L)
lymphocyte count <800/mm3 (<0.8 X 109 / L)

Where it is running

Neurologique Foundation, Inc. — Ponte Vedra, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.