Multiple Sclerosis, Relapsing-RemittingPhase 3StarTecNCT02579681
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
A Phase 3 study testing dimethyl fumarate in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 18 sites in Italy.
Trial summary
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 18 sitesItaly
- Study dates
- 30 Apr 2014to 21 Dec 2016
- 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
- Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
Who cannot join
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
Research site
Bari
Research site
Cagliari
Research site
Catania
Research site
Cefalù
Research site
Chieti
Research site
Ferrara
Research site
Fidenza
Research site
Florence
Research site
Gallarate
Research site
Genova
Research site
L’Aquila
Research site
Milan
Research site
Naples
Research site
Orbassano
Research site
Padova
Research site
Palermo
Research site
Pavia
Research site
Roma
About this study
Official title: Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- dimethyl fumarate
- Keywords
- Cognition, Tecfidera, RRMS, BG00012
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called Tecfidera, DMF, BG00012
dimethyl fumarate administered as per the arm description
| Study group | Role | What they receive |
|---|---|---|
| BG00012 | Experimental | BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter. Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with worsening in cognitive improvement over 2 years.
As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.
Measured: Up to 2 years
Secondary outcomes (10)
Change in cognitive impairment index score (CII) over two years
An individual cognitive change index will be measured by calculating changes on the cognitive impairment index (CII) for each participant between year 0 and year 1, and year 0 and year 2. The CII is an individual cognitive change index aimed at providing a more precise assessment of the amount and direction of cognitive changes over time.
Measured: Up to 2 years
Annualized relapse rate at year 1.
Measured: Up to one year
Annualized relapse rate at year 2.
Measured: Up to 2 years
Time to relapse over 2 years.
Measured: 2 years
Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. Each functional system is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability). EDSS steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.
Measured: Up to 2 years
Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
Demographics may include age and gender, disease characteristics may include year of diagnosis and disability and PRO may include fatigue and depression at the time of initiation of BG00012.
Measured: Up to 2 years
Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
The MADRS instrument has nine questions, with an overall score ranging from 0 to 27 points
Measured: 2 years
Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
The MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items
Measured: 2 years
Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
The EQ-5D is a widely-used survey instrument for measuring economic preferences for health states. It is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety).
Measured: 2 years
Change from baseline in the Environmental Status Scale (ESS)
The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start30 Apr 2014
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579681
- Sponsor's protocol ID
- ITA-BGT-12-10389
- Other IDs
- 2013-001422-25, 109MS410
- Acronym
- StarTec
- Status last verified
- Apr 2017
- First submitted
- 16 Oct 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
- ClinicalTrials.gov ID
- NCT02579681
- Acronym / sponsor ID
- StarTec / ITA-BGT-12-10389
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Cognition, Tecfidera, RRMS, BG00012
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 20 Oct 2015 (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 primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BG00012 | Experimental | Drug: dimethyl fumarateBG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
Key exclusion criteria (5 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.
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 |
|---|---|---|
| dimethyl fumarateAlso: Tecfidera, DMF, BG00012dimethyl fumarate administered as per the arm description | Drug | BG00012 |
Primary outcome
Proportion of patients with worsening in cognitive improvement over 2 years.
Time frame: Up to 2 years
As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.
10 secondary outcomes
Change in cognitive impairment index score (CII) over two years
Time frame: Up to 2 years
Annualized relapse rate at year 1.
Time frame: Up to one year
Annualized relapse rate at year 2.
Time frame: Up to 2 years
Time to relapse over 2 years.
Time frame: 2 years
Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).
Time frame: Up to 2 years
Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
Time frame: Up to 2 years
Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
Time frame: 2 years
Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
Time frame: 2 years
Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
Time frame: 2 years
Change from baseline in the Environmental Status Scale (ESS)
Time frame: 2 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 27 Apr 2017.
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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.
Medical Director study director
Biogen
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dimethyl fumarate in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 18 sites in Italy.
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 5 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. 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 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?
Proportion of patients with worsening in cognitive improvement over 2 years. (time frame: Up to 2 years). 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 27 Apr 2017.