NCT01201343

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).

Conditions

• Multiple Sclerosis, Relapsing, Remitting

Interventions

Type	Name	Description
DRUG	Interferon beta-1a

Timeline

• Start date: 2005-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-09-14
• Last updated: 2013-12-27
• Results posted: 2012-04-11