BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

Bayer0 sites138 target enrollmentDecember 6, 2012

ConditionsMultiple Sclerosis

InterventionsInterferon beta-1b (Betaferon, BAY 86-5046)

DrugsInterferon beta-1b (Betaferon, BAY 86-5046)

Overview

Phase: Not Applicable
Intervention: Interferon beta-1b (Betaferon, BAY 86-5046)
Conditions: Multiple Sclerosis
Sponsor: Bayer
Enrollment: 138
Primary Endpoint: Functional health status assessed by Short Form-36 (SF-36)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2012

End Date

March 14, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤
•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.

Arms & Interventions

Group 1

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

Outcomes

Primary Outcomes

Functional health status assessed by Short Form-36 (SF-36)

Time Frame: up to 3 years

Fatique assessed by the Modified Fatigue Impact Scale (MFIS)

Time Frame: up to 3 years

Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)

Time Frame: up to 3 years

Secondary Outcomes

Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)(up to 3 years)
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)(up to 3 years)
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)(up to 3 years)
Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.(up to 3 years)