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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: December 7, 2012
Last updated: March 15, 2016
Last verified: March 2016
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.

Condition Intervention
Multiple Sclerosis
Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Fatique assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Patients will be followed-up for 24 months


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01766063

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01766063     History of Changes
Other Study ID Numbers: 16352  BF1212DE 
Study First Received: December 7, 2012
Last Updated: March 15, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Multiple Sclerosis
Quality of life
Observational study

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Interferon beta-1b
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 30, 2016