check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
16352
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
138Trial Dates
December 2012 - March 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany |
Primary Outcome
- Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Fatique assessed by the Modified Fatigue Impact Scale (MFIS)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- 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 yearsenhanced_encryptionNoSafety Issue:
- Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
- Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.date_rangeTime Frame:up to 3 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A