check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

16352

ClinicalTrials.gov Identifier:

NCT01766063

EudraCT Number:

Not Available

EU CT Number:

Not Available
Investigating the relationship between sleep, quality of life,other disorders and therapies in MS patients on Betaferon

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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
December 2012 - March 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Functional health status assessed by Short Form-36 (SF-36)
    date_rangeTime Frame:
    up to 3 years

Secondary Outcome

  • Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
    date_rangeTime Frame:
    up to 3 years
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    Safety Issue:
    No
  • Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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