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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766063
First Posted: January 11, 2013
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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 ]
  • Fatique assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: up to 3 years ]

Secondary Outcome Measures:
  • Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS) [ Time Frame: up to 3 years ]
  • Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS) [ Time Frame: up to 3 years ]
  • Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL) [ Time Frame: 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 ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: up to 3 years ]

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

  Eligibility

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.

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.
  Contacts and Locations
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


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01766063     History of Changes
Other Study ID Numbers: 16352
BF1212DE ( Other Identifier: Company internal )
First Submitted: December 7, 2012
First Posted: January 11, 2013
Last Update Posted: March 27, 2017
Last Verified: March 2017

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

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