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NCT Number: NCT01081782

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brugge Clinical Site 203, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ONO-4641

Drug

0.15 mg once per day for 26 weeks

ONO-4641 placebo

Drug

Placebo once per day for 26 weeks

Primary outcomes

  1. Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.

    Time frame: 26 weeks

Secondary outcomes

  1. Total volume of Gd-enhanced lesions

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

Acronym: DreaMS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2010
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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