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

NCT ID: NCT01766063

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-06

Study Completion Date

2017-03-14

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

Patients will be followed-up for 24 months

Interventions

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

Patients will be followed-up for 24 months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30143019 (View on PubMed)

Other Identifiers

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BF1212DE

Identifier Type: OTHER

Identifier Source: secondary_id

16352

Identifier Type: -

Identifier Source: org_study_id

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