drugset / Trial / NCT03752307

Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses

NCT03752307

Phase 1/2 Completed 2 enrolled University of New Mexico
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a proof of concept, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of Isoxsuprine in MS subjects experiencing a typical relapse. Evidence from preclinical stroke models and experimental allergic encephalomyelitis suggest that isoxsuprine hydrochloride may have neuroprotective activity and reduce disability in animal models. Given its potential neuroprotective effects in CNS injury models, the investigators propose to test it as a safe, tolerable add on treatment for acute relapses in patients with relapsing forms of MS.

Timeline

Start
2019-02-15
Primary completion
2023-07-06
Completion
2023-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ISOXSUPRINE Small molecule 10 mg Oral
Background Methylprednisolone Other / unclassified 1000 mg Intravenous
Background Prednisone Other / unclassified 600 mg Oral

Indications