Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment interferon beta-1b (betaferon, bay 86-5046)
Phase phase 4
Sponsor Bayer
Start date December 2012
End date December 2016
Trial size 138 participants
Trial identifier NCT01766063, 16352, BF1212DE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
interferon beta-1b (betaferon, bay 86-5046)
Patients will be followed-up for 24 months

Primary Outcomes

Measure
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
time frame: up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
time frame: up to 3 years

Secondary Outcomes

Measure
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
time frame: up to 3 years
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
time frame: up to 3 years
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
time frame: up to 3 years
Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.
time frame: up to 3 years
Safety variables will be summarized using descriptive statistics based on adverse events collection
time frame: up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.