Multiple SclerosisBetaSleepNCT01766063
Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaferon, BAY 86-5046)
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2012to 14 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon, BAY 86-5046)
- Keywords
- Multiple Sclerosis, Sleep, Quality of life, Observational study
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon, BAY 86-5046)Drug
Patients will be followed-up for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon beta-1b (Betaferon, BAY 86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
Measured: up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
Measured: up to 3 years
Functional health status assessed by Short Form-36 (SF-36)
Measured: up to 3 years
Secondary outcomes (4)
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
Measured: up to 3 years
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
Measured: up to 3 years
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
Measured: up to 3 years
Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study start6 Dec 2012
- Primary completion9 Jan 2017
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766063
- Sponsor's protocol ID
- 16352
- Other IDs
- BF1212DE
- Acronym
- BetaSleep
- Status last verified
- Feb 2018
- First submitted
- 7 Dec 2012
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30143019
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients
- ClinicalTrials.gov ID
- NCT01766063
- Acronym / sponsor ID
- BetaSleep / 16352
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Sleep, Quality of life, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon beta-1b (Betaferon, BAY 86-5046) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1b (Betaferon, BAY 86-5046)Patients will be followed-up for 24 months | Drug | Group 1 |
Primary outcome
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)
Time frame: up to 3 years
Functional health status assessed by Short Form-36 (SF-36)
Time frame: up to 3 years
4 secondary outcomes
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)
Time frame: up to 3 years
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)
Time frame: up to 3 years
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)
Time frame: up to 3 years
Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 30143019Kotterba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) (time frame: up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.