A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis (DreaMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck KGaA
Ono Pharmaceuticals Co. Ltd., Japan
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01226745
First received: October 19, 2010
Last updated: June 18, 2014
Last verified: June 2014

October 19, 2010
June 18, 2014
October 2010
June 2016   (final data collection date for primary outcome measure)
The long-term safety and tolerability of ONO-4641 (MSC2430913A) using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
The long-term safety and tolerability of ONO-4641 using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01226745 on ClinicalTrials.gov Archive Site
  • The number of Gd-enhanced lesions obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
  • Lesion volume obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
  • Brain volume obtained by MRI [ Time Frame: 229 weeks ] [ Designated as safety issue: Yes ]
  • The number of Gd-enhanced lesions obtained by MRI [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Lesion volume obtained by MRI [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Brain volume obtained by MRI [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis
A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: ONO-4641 (MSC2430913A)
    0.15 mg once per day for 225 weeks
  • Drug: ONO-4641 (MSC2430913A)
    0.1 mg once per day for 225 weeks
  • Drug: ONO-4641 (MSC2430913A)
    0.05 mg once per day for 225 weeks
  • Experimental: E1
    Intervention: Drug: ONO-4641 (MSC2430913A)
  • Experimental: E2
    Intervention: Drug: ONO-4641 (MSC2430913A)
  • Experimental: E3
    Intervention: Drug: ONO-4641 (MSC2430913A)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
343
Not Provided
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Czech Republic,   Germany,   Greece,   Japan,   Poland,   Russian Federation,   Spain,   Ukraine
 
NCT01226745
ONO-4641POU007 (EMR200559-002), 2010-018705-11
Yes
EMD Serono
EMD Serono
  • Merck KGaA
  • Ono Pharmaceuticals Co. Ltd., Japan
Study Director: Medical Responsible EMD Serono, Inc.
Study Director: Study Director Ono Pharmaceuticals Co. Ltd., Japan
EMD Serono
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP