Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects, 18-50 years of age
Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
At least 2 years history of MS before trial entry
Documented history of 2 or more exacerbations in the 2 years prior to trial entry
Stable neurological status for at least 30 days before first study drug administration
Have an EDSS from 0-5.5
If female, she must either
Willingness and ability to comply with the protocol for the duration of the study
In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
218 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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