A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis (DreaMS)

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: ONO-4641; Drug: ONO-4641 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081782

ONO-4641POU006

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.

Enrollment: 407 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female aged 18-55 years inclusive at screening
• Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

Exclusion criteria

• Multiple Sclerosis course other than relapsing-remitting multiple sclerosis
• History of malignancy
• History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)
• Inability to undergo Gd-enhanced MRI scans
• Diagnosis of diabetes mellitus (type I or type II)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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407 participants in 4 patient groups, including a placebo group

E1

Experimental group

Treatment:

Drug: ONO-4641

Drug: ONO-4641

Drug: ONO-4641

E2

Experimental group

Treatment:

Drug: ONO-4641

Drug: ONO-4641

Drug: ONO-4641

E3

Experimental group

Treatment:

Drug: ONO-4641

Drug: ONO-4641

Drug: ONO-4641

P

Placebo Comparator group

Treatment:

Drug: ONO-4641 placebo