drugset / Trial / NCT01191996
Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis
Phase 1/2
Completed
34 enrolled
Innate Immunotherapeutics
National Multiple Sclerosis Society · collabPrimorus Clinical Trials · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to determine the safety and tolerability, dose-limiting toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously administered MIS416 weekly in patients with chronic progressive multiple sclerosis.
Timeline
- Start
- 2010-08
- Primary completion
- 2012-06
- Completion
- 2012-11
Publications
- Webster GA, Sim DA, La Flamme AC, Mayo NE. Evaluation of neurological changes in secondary progressive multiple sclerosis patients treated with immune modulator MIS416: results from a feasibility study. Pilot Feasibility Stud. 2017 Nov 16;3:60. doi: 10.1186/s40814-017-0201-4. eCollection 2017.
- Luckey AM, Anderson T, Silverman MH, Webster G. Safety, tolerability and pharmacodynamics of a novel immunomodulator, MIS416, in patients with chronic progressive multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 May 12;1:2055217315583385. doi: 10.1177/2055217315583385. eCollection 2015 Jan-Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MIS416 | Unknown | 500 ug | Intravenous |