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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01766063
• Date of registration: 07/12/2012
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon BetaSleep
• Scientific title: BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
• Date of first enrolment: December 6, 2012
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01766063
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1b (Betaferon, BAY 86-5046)

Primary Outcome(s)

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

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]

Secondary Outcome(s)

Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS) [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]

Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS) [Time Frame: up to 3 years]

Secondary ID(s)

BF1212DE

16352

Source(s) of Monetary Support

Please refer to primary and secondary sponsors