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

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ClinicalTrials.gov Identifier: NCT01766063
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):

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.

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

Study Type : Observational
Actual Enrollment : 138 participants
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
Actual Study Start Date : December 6, 2012
Primary Completion Date : January 9, 2017
Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766063

Multiple Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01766063     History of Changes
Other Study ID Numbers: 16352
BF1212DE ( Other Identifier: Company internal )
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic