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NCT Number: NCT01766063

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Patients will be followed-up for 24 months

Primary outcomes

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

    Time frame: up to 3 years

  2. Fatique assessed by the Modified Fatigue Impact Scale (MFIS)

    Time frame: up to 3 years

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

    Time frame: up to 3 years

Secondary outcomes

  1. Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)

    Time frame: up to 3 years

  2. Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)

    Time frame: up to 3 years

  3. Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)

    Time frame: up to 3 years

  4. Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.

    Time frame: up to 3 years

Other outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: BetaSleep

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2013
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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