Status:
COMPLETED
Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A.S, France
Conditions:
Multiple Sclerosis, Relapsing, Remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with ...
Detailed Description
This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeuti...
Eligibility Criteria
Inclusion
- Male and female subjects aged ≥ 18 years
- Subjects with RRMS
- Subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
- Subjects with indication of IFN beta treatment determined by the investigator
- Other protocol-defined inclusion criteria may apply
Exclusion
- Subjects with secondary progressive multiple sclerosis (MS) without relapse
- Subjects with ongoing acute relapse
- Subjects already being treated with interferon
- Subjects with corticoid therapy for less than 15 days
- Subjects presenting acute major depression or treated with anti-depressant therapy
- Subjects involved in another therapeutic study
- Subjects with any condition which could interfere with a good compliance of this study
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01201343
Start Date
January 1 2005
End Date
July 1 2010
Last Update
December 27 2013
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