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

ID: NCT01766063
Status: Completed
Phase: N/A
Start Date: December 06, 2012
First Submitted: December 07, 2012
Last Updated: February 15, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Germany
Conditions: Multiple Sclerosis
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Multiple Sclerosis

Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Other Names
N/A

Tracking Information

First Submitted DateDecember 07, 2012
Last Update Posted DateFebruary 15, 2018
Actual Start DateDecember 06, 2012
Actual Completion DateMarch 14, 2017
Actual Primary Completion DateJanuary 09, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Functional health status assessed by Short Form-36 (SF-36) [Time Frame: up to 3 years]

  • Fatique assessed by the Modified Fatigue Impact Scale (MFIS) [Time Frame: up to 3 years]

  • Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time Frame: up to 3 years]

Original Primary Outcome Measures

Not Available

Current 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleInvestigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon
Official TitleBETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
138
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Multiple Sclerosis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationThe 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.
Intervention
Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

Patients will be followed-up for 24 months

Other Names
Study Groups/Cohorts
Group 1

Study Arms
Group 1
Drug : Interferon beta-1b (Betaferon, BAY 86-5046)
Patients will be followed-up for 24 months

Arm Intervention/Treatment
Group 1
Drug : Interferon beta-1b (Betaferon, BAY 86-5046)

Recruitment Information

Recruitment Status:Completed
Enrollment138
Completion DateMarch 14, 2017
Eligibility 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Germany

Administrative Information

NCT Number:NCT01766063
Other Study ID Numbers
16352
BF1212DE
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer