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

Multiple Sclerosis Clinical Trial

— BetaSleep  

Official title:

BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766063
• Other study ID #: 16352
• Secondary ID: BF1212DE
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: February 15, 2018
• Start date: December 6, 2012
• Est. completion date: March 14, 2017

Study information

• Verified date: February 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 14, 2017
• Est. primary completion date: January 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety variables will be summarized using descriptive statistics based on adverse events collection		up to 3 years
Primary	Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)		up to 3 years
Primary	Fatique assessed by the Modified Fatigue Impact Scale (MFIS)		up to 3 years
Primary	Functional health status assessed by Short Form-36 (SF-36)		up to 3 years
Secondary	Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)		up to 3 years
Secondary	Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)		up to 3 years
Secondary	Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)		up to 3 years
Secondary	Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.		up to 3 years

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