Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004744
• Date of registration: 24/02/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
• Date of first enrolment: February 1993
• Target sample size: 76
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004744
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: John H. Noseworthy
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Clinically or laboratory-supported definite multiple sclerosis

- Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive)

- Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb
Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on
Medical Research Clinic muscle power scale

- Documented by Mayo Clinic Department of Neurology as neither progressing nor
improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or
corticosteroid-induced improvement

- Able to cooperate with isometric strength testing requirements

--Prior/Concurrent Therapy--

- No concurrent experimental drug therapy

- No concurrent intravenous immune globulin At least 3 months since immunosuppressive
therapy, e.g., corticosteroids and corticotropin

- At least 3 months since plasma exchange

--Patient Characteristics--

- Hepatic: No coagulation defect, e.g., hyperviscosity syndrome

- Renal: Creatinine no greater than 1.5 times normal

- Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.:
angina congestive heart failure transient ischemic attack stroke

- Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia
No known antibody deficiency syndrome, especially IgA deficiency

Other:

- No condition interfering with neurologic exam, e.g.:

- Major amputation

- Deforming arthritis

- Major psychiatric illness

- Superimposed lower motor neuron deficit

- No intellectual impairment precluding study participation

- No pregnant or nursing women

- Adequate contraception required of fertile patients



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: immune globulin

Secondary ID(s)

MAYOC-27992

199/11660

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mayo Clinic