Multiple SclerosisPhase 3NCT00313976
Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
A Phase 3 study testing Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) in people with Multiple Sclerosis, run by Bayer at 7 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS). 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/Betaseron, BAY86-5046)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
Who may be able to join
- Diagnosis of MS for no less than one year and no longer than ten years
- Disease in the secondary progressive (SP) phase
- At least one relapse the last 3 years
- Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months
Who cannot join
- Serious or acute heart disease
- Severe depression
- Serious or acute liver, kidney or bone marrow dysfunction
- Epilepsy not adequately treated
- Pregnancy or lactation
- Alcohol or drug abuse
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Denmark4 sites
Study site
Ask Contact
Study site
Copenhagen, DK-2100
Study site
Hillerød, DK-3400
Study site
Holstebro, DK-7500
Sweden3 sites
Study site
Stockholm, 11281
Study site
Stockholm, 14186
Study site
Stockholm, 171 76
About this study
Official title: A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
- Keywords
- Multiple Sclerosis, Early secondary progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)Drug
250 micrograms every other day, subcutaneously for 104 weeks
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)Drug
2x250 micrograms every other day, subcutaneously for 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 2 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI): T2-lesions
Measured: At week 104
Secondary outcomes (6)
Further Magnetic Resonance Imaging (MRI) parameters
Measured: At week 104
Relapses
Measured: At week 104
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Measured: At week 104
Hospitalizations
Measured: At week 104
Neutralizing antibodies
Measured: At week 104
Adverse events
Measured: At week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313976
- Sponsor's protocol ID
- 91449
- Other IDs
- EudraCT: 2005-001540-23, 309560
- Status last verified
- Dec 2008
- First submitted
- 11 Apr 2006
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00313976
- Acronym / sponsor ID
- 91449
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Early secondary progressive Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 12 Apr 2006 (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 purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 2 | Experimental | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MS for no less than one year and no longer than ten years
- Disease in the secondary progressive (SP) phase
- At least one relapse the last 3 years
- Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months
Key exclusion criteria (6 listed)
- Serious or acute heart disease
- Severe depression
- Serious or acute liver, kidney or bone marrow dysfunction
- Epilepsy not adequately treated
- Pregnancy or lactation
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/Betaseron, BAY86-5046)250 micrograms every other day, subcutaneously for 104 weeks | Drug | Arm 1 |
| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)2x250 micrograms every other day, subcutaneously for 104 weeks | Drug | Arm 2 |
Primary outcome
Magnetic Resonance Imaging (MRI): T2-lesions
Time frame: At week 104
6 secondary outcomes
Further Magnetic Resonance Imaging (MRI) parameters
Time frame: At week 104
Relapses
Time frame: At week 104
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Time frame: At week 104
Hospitalizations
Time frame: At week 104
Neutralizing antibodies
Time frame: At week 104
Adverse events
Time frame: At week 104
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) in people with Multiple Sclerosis, run by Bayer at 7 sites in 2 countries.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark, Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Magnetic Resonance Imaging (MRI): T2-lesions (time frame: At week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.