Trial record 1 of 2 for:
ONO-4641
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:
EMD Serono
Collaborators:
Merck Serono S.A., Genenva, Switzerland
Ono Pharmaceuticals Co. Ltd., Japan
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01226745
First received: October 19, 2010
Last updated: February 7, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 19, 2010 | ||||||||
| Last Updated Date | February 7, 2013 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The long-term safety and tolerability of ONO-4641 (MSC2430913A) using vital signs, pulmonary function tests, ECGs, dermatological and ophthalmologic examinations [ Time Frame: 122 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT01226745 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis | ||||||||
| Official Title ICMJE | A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis | ||||||||
| Brief Summary | 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). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Sclerosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 376 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Belgium, Canada, Czech Republic, Germany, Greece, Japan, Poland, Russian Federation, Spain, Ukraine | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01226745 | ||||||||
| Other Study ID Numbers ICMJE | ONO-4641POU007 (EMR200559-002), 2010-018705-11 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | EMD Serono | ||||||||
| Study Sponsor ICMJE | EMD Serono | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | EMD Serono | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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