Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon (BetaSleep)

Bayer

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

Study type: Observational

Funder types: Industry

Identifiers

NCT01766063

BF1212DE (Other Identifier)

16352

Details and patient eligibility

About

The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤5.
• Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator's evaluation, but should not have received Betaferon longer than six months.
• Written informed consent must be obtained

Exclusion criteria

• Patients who do not tolerate Betaferon according to the investigator's evaluation or have been treated with Betaferon for more than six months.
• Patients receiving any other disease modifying drug or MS specific treatments
• Contraindications of Betaferon described in the Summary of Product Characteristics.

Trial design

138 participants in 1 patient group

Group 1

Treatment:

Drug: Interferon beta-1b (Betaferon, BAY 86-5046)