drugset / Trial / NCT02446886

Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS

NCT02446886

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine if monthly pulse doses of a three-day course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course of treatment. The main secondary objective is to utilize every three month MWF measurements to determine the peak time of remyelination in new multiple sclerosis lesions when followed over the course of 12 months.

Timeline

Start
2016-06
Primary completion
2020-03
Completion
2020-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 80 iu Subcutaneous
Subject Insulin Protein / enzyme biologic 120 iu Subcutaneous

Indications