Clinical trial NCT00947895: Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Official title: Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: ACTH
Acthar gel
adrenocorticotropin
methylprednisolone
solumedrol
MS
multiple
sclerosis
relapse
exacerbation
sub-responsive
IV
Lead sponsor: Neurologique Foundation, Inc.
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2009-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ponte Vedra
country: United States
facility: Neurologique Foundation, Inc.
state: Florida
Study officials:
affiliation: Neurologique Foundation, Inc.
name: Daniel Kantor, MD
role: PRINCIPAL_INVESTIGATOR
References: