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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01766063
First received: December 7, 2012
Last updated: July 29, 2014
Last verified: July 2014
  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 ] [ 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 ]

Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (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

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.

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
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 ClinicalTrials.gov identifier: NCT01766063

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01766063     History of Changes
Other Study ID Numbers: 16352, BF1212DE
Study First Received: December 7, 2012
Last Updated: July 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on August 21, 2014