drugset / Trial / NCT01226745

Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT01226745 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).

Timeline

Start
2010-10
Primary completion
2015-01
Completion
2015-01

Outcome

Outcome not reported

Stopped: “Merck has decided to not pursue phase 3 development of ceralifimod (ONO-4641). The decision was not related to any safety and efficacy findings”

Publications

  • Results Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161) Amit Bar-Or, Frauke Zipp, Matthew Scaramozza, Timothy Vollmer, Bryan Due, Karthinathan Thangavelu, Tanya Fischer, and Krzysztof Selmaj April 8, 2014 82:10 Supplement P3.161; 1526-632X

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-4641 Unknown 0.05 mg —
Subject ONO-4641 Unknown 0.1 mg —
Subject ONO-4641 Unknown 0.15 mg —

Indications