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

February 15, 2018 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) with an Expanded Disability Status Scale (EDSS) score ≤5 who tolerate Betaferon according to the investigator's evaluation, but have not received Betaferon longer than six months. Participants will be recruited from private neurological offices and neurology departments throughout Germany.

In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician.

The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Patients will be followed-up for 24 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
Time Frame: up to 3 years
up to 3 years
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
Time Frame: up to 3 years
up to 3 years
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
Time Frame: up to 3 years
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
up to 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

January 9, 2017

Study Completion (Actual)

March 14, 2017

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16352
  • BF1212DE (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Interferon beta-1b (Betaferon, BAY 86-5046)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe