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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: ONO-4641

Study type

Interventional

Funder types

Industry

Identifiers

NCT01226745

2010-018705-11 (EudraCT Number)

ONO-4641POU007 (EMR200559-002)

Details and patient eligibility

About

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]).

Enrollment

340 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed 26 weeks of double-blind phase of Study ONO-4641POU006

Exclusion criteria

Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

340 participants in 6 patient groups

ONO-4641 0.15 milligram (mg) - 0.15 mg

Experimental group

Treatment:

Drug: ONO-4641

ONO-4641 0.10 mg - 0.10 mg

Experimental group

Treatment:

Drug: ONO-4641

ONO-4641 0.05 mg - 0.05 mg

Experimental group

Treatment:

Drug: ONO-4641

Placebo - ONO4641 0.15 mg

Experimental group

Treatment:

Drug: ONO-4641

Placebo - ONO4641 0.10 mg

Experimental group

Treatment:

Drug: ONO-4641

Placebo - ONO4641 0.05 mg

Experimental group

Treatment:

Drug: ONO-4641

Trial contacts and locations

70

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