Clinical trial NCT01766063: Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon
Official title: BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Sleep
Quality of life
Observational study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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 ≤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.

Primary outcomes:
measure: Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to 3 years
measure: Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
timeFrame: up to 3 years
measure: Functional health status assessed by Short Form-36 (SF-36)
timeFrame: up to 3 years
Secondary outcomes:
measure: Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
timeFrame: up to 3 years
measure: Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
timeFrame: up to 3 years
measure: Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
timeFrame: up to 3 years
measure: Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.
timeFrame: up to 3 years
Other outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: up to 3 years
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kotterba S, Neusser T, Norenberg C, Bussfeld P, Glaser T, Dorner M, Schurks M. Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study. BMC Neurol. 2018 Aug 24;18(1):123. doi: 10.1186/s12883-018-1113-5.