Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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 no change of therapeutic behavior but with standardized neuropsychologic follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.A.S, France
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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