drugset / Trial / NCT00854750

Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

NCT00854750

Phase 4 Terminated 1 enrolled Elliot Frohman Mallinckrodt · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The investigators principal hypothesis is that INO and optic neuritis are objective, quantitative, and reproducible models for corroborating the hypothesis that changes in core body temperature are associated with the reversible and stereotypic decay in axonal conduction and that ACTHAR can serve to prevent such changes. The application of ocular motor and optic nerve measures appears to constitute a useful paradigm to detect and monitor responses to therapeutic strategies that stabilize nerve cell membranes in response to temperature induced decay in axonal conduction mechanisms, with implications on activities of daily life that are dependent upon vision (reading, driving, walking, work performance).

Timeline

Start
2009-05
Primary completion
2010-05
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Acthar Peptide 20 mg Subcutaneous
Subject Acthar Peptide 40 mg Subcutaneous
Subject Acthar Peptide 80 mg Subcutaneous

Indications