Trial Condition(s):
Multiple Sclerosis
Investigating the relationship between sleep, quality of life,other disorders and therapies in MS patients on Betaferon (BetaSleep)
Bayer Identifier:
16352
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial 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.
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.
Trial Summary
Enrollment Goal
138
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
BETASLEEP - SLEEP quality and functional health status, fatigue, comorbidities and therapeutic algorithms among BETAferon® treated MS patients
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)Timeframe: up to 3 years
- Fatique assessed by the Modified Fatigue Impact Scale (MFIS)Timeframe: up to 3 years
- Functional health status assessed by Short Form-36 (SF-36)Timeframe: up to 3 years
Secondary Outcome
- Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)Timeframe: up to 3 years
- Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)Timeframe: up to 3 years
- Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)Timeframe: up to 3 years
- Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.Timeframe: up to 3 years
Additional Information
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