Multiple Sclerosis
Conditions
Keywords
ACTH, Acthar gel, adrenocorticotropin, methylprednisolone, solumedrol, MS, multiple, sclerosis, relapse, exacerbation, sub-responsive, IV
Brief summary
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.
Interventions
DRUGMethylprednisolone
IV 1000 mg daily for 3 days
DRUGACTH
IM ACTH 80 mg/day for 5 days.
OTHERIV placebo
IV placebo (saline) daily for 3 days.
OTHERIM placebo
IM placebo (saline) daily for 5 days.
Sponsors
Mallinckrodt
Neurologique Foundation, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components. | 12 weeks |
| Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone. | 12 weeks |
Countries
United States
Outcome results
None listed