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Relapsing-Remitting Multiple SclerosisPhase 4TECNERGYNCT02090348

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate

A Phase 4 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dimethyl fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2015to Oct 2017
Phase
Phase 4
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

  • Have a confirmed diagnosis of RRMS and satisfies the therapeutic indication as described in the local label.
  • Have a stable EDSS (as assessed by the Investigator) and been on the same (type and dosage) standard of care (SOC) first-line treatment for at least 6 months.
  • If taking antidepressants, amphetamine, modafinil, or fampridine (Fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the Baseline Visit.
  • FSMC total score ≥43 (mild fatigue) at Baseline.
  • As perceived by the Investigator, have the ability to comply with all requirements of the study protocol.

Who cannot join

  • Diagnosis of major depression, as identified by the Investigator.
  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
  • History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
  • Treatment of MS relapse within 90 days prior to study enrollment.
  • History of a positive test result for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody.
  • Impaired hepatic or renal function, as perceived by the Investigator.
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  • Any prior treatment with DMF (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, T cell or T-cell receptor vaccination, or any therapeutic monoclonal antibody.
  • Current enrollment in any other clinical studies.
  • Known to suffer from narcolepsy or another significant sleep disorder.
  • Comorbidity that may have an impact on fatigue.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
  • NOTE: Other protocol-defined Inclusion/Exclusion Criteria May Apply

About this study

Official title: A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]), health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS]) at 6 and 12 months in participants receiving DMF; To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication use.

Being tested
dimethyl fumarate
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dimethyl fumarateDrug

    Also called DMF, BG00012, Tecfidera

    Administered as specified in the treatment arm

Study groups in NCT02090348
Study groupRoleWhat they receive
dimethyl fumarateExperimentalDMF at a dose of 120 mg twice a day (BID) for the first 7 days and 240 mg BID for the remainder of study period (up to 12 months)
Receives: Drug: dimethyl fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF

    FSMC is a 20-item questionnaire and produces a score between 1 and 5 for each scored question (ranging from "does not apply at all" to "applies completely"). Items are summed to generate a total score and transformed to a scale with a range of 20 to 100, where higher scores indicate higher levels of fatigue

    Measured: 12 months

Secondary outcomes (9)

  1. Mean change from baseline in fatigue as assessed by FSMC in participants receiving DMF

    Measured: Baseline and 1, 3, 6, 9 and 12 months

  2. Mean change from baseline in fatigue as assessed by FSS in participants receiving DMF

    The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. FSS consists of answering a 9-item questionnaire that requires the participant to rate his or her own level of fatigue. Each question produces a score between 1 to 7. The scoring is done by calculating the average response to the questions. Participants with depression alone score about 4.5. But people with fatigue related to MS average about 6.5

    Measured: Baseline and 1, 3, 6, 9 and 12 months

  3. Mean change from baseline in work productivity as assessed by WPAI-MS, in participants receiving DMF

    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity

    Measured: Baseline and 6, 12 months

  4. Mean change from baseline in quality of life as assessed by SF-12 in participants receiving DMF

    The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health

    Measured: Baseline and 6, 12 months

  5. Mean change from baseline in depression as assessed by BDI-FS in participants receiving DMF

    BDI-FS is a self-report inventory for measuring the severity of depression on a 7-item questionnaire. Each question is rated on a 4-point scale (0 - 3) to assess frequency, over the past two weeks, of feelings of sadness, pessimism (hopelessness), sense of failure, loss of a sense of pleasure, loss of self-confidence, self-blame, and suicidal ideation. The total ESS score is the sum of 8 item-scores and can range between 0 and 21, where higher scores indicate higher levels of depression

    Measured: Baseline and 6, 12 months

  6. Mean change from baseline in sleepiness assessed by ESS in participants receiving DMF

    The ESS is a self-administered 8-item questionnaire with that provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. Each question is rated on a 4-point scale (0 - 3), their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives, although not necessarily every day. The total ESS score is the sum of 8 item-scores and can range between 0 and 24, where higher scores indicate higher levels of a person's level of daytime sleepiness

    Measured: Baseline and 6, 12 months

  7. Change in MS-related fatigue (FSMC) status

    Improved (> 4.5 increase), Stable (within ±4.5), and Worsened (> 4.5 decrease)

    Measured: Baseline and up to 12 months

  8. Correlation of fatigue with baseline demographics and disease characteristics

    Measured: Baseline and up to 12 months

  9. Proportion of participants with reduced dose or discontinuation of fatigue-related medications

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Why it stopped: The study was withdrawn for business reasons. The decision to stop the TECNERGY study was not a result of any safety or efficacy concerns.

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02090348
Sponsor's protocol ID
109MS405
Other IDs
2013-001025-53, DEN-BGT-13-10413
Acronym
TECNERGY
Status last verified
Sep 2015
First submitted
14 Mar 2014
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen.

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 5 inclusion and 12 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF (time frame: 12 months). 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 NCT02090348.

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 7 Sep 2015.

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