NCT01766063

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

December 7, 2012

Last Update Submit

February 15, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisSleepQuality of lifeObservational study

Outcome Measures

Primary Outcomes (3)

  • Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)

    up to 3 years

  • Fatique assessed by the Modified Fatigue Impact Scale (MFIS)

    up to 3 years

  • Functional health status assessed by Short Form-36 (SF-36)

    up to 3 years

Secondary Outcomes (4)

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

    up to 3 years

  • Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)

    up to 3 years

  • Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)

    up to 3 years

  • Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.

    up to 3 years

Other Outcomes (1)

  • Safety variables will be summarized using descriptive statistics based on adverse events collection

    up to 3 years

Study Arms (1)

Group 1

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

Interventions

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

Patients will be followed-up for 24 months

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) with an Expanded Disability Status Scale (EDSS) score ≤5 who tolerate Betaferon according to the investigator's evaluation, but have not received Betaferon longer than six months. Participants will be recruited from private neurological offices and neurology departments throughout Germany. In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician. The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

Related Publications (1)

  • Kotterba S, Neusser T, Norenberg C, Bussfeld P, Glaser T, Dorner M, Schurks M. Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study. BMC Neurol. 2018 Aug 24;18(1):123. doi: 10.1186/s12883-018-1113-5.

    PMID: 30143019DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2012

First Posted

January 11, 2013

Study Start

December 6, 2012

Primary Completion

January 9, 2017

Study Completion

March 14, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

DE(1)