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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

• Registration Number: NCT01766063
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-06
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Primary Completion: 2017-01-09
• Study Completion: 2017-03-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Functional health status assessed by Short Form-36 (SF-36)	up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)	up to 3 years
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)	up to 3 years

Secondary Outcome Measures

Name	Time	Method
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