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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis, Relapsing, Remitting

Treatments

Drug: Interferon beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

NCT01201343

IMP 25206

Details and patient eligibility

About

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.

Full 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).

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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