Lennox-Gastaut SyndromeNCT01991041
European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
An observational study of Lennox-Gastaut Syndrome, run by Eisai Limited at 49 sites in 8 countries.
Trial summary
This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Lennox-Gastaut Syndrome
- How many people
- 109 participants
- Where
- 49 sitesin 8 countries
- Study dates
- Jun 2008to Nov 2015
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participation in this study will be offered to any patient of four years or older, who has a known diagnosis of LGS, who requires a change in anti-epileptic therapy. This will include patients who are started on rufinamide, as an adjuvant therapy.
Who may be able to join
- Patients will be four years and older
- Patients will have an established diagnosis of Lennox-Gastaut syndrome, and:
- Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences)
- Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity)
- Presence of intellectual / learning disability (a variable degree is permitted)
- Patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. This includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy
Who cannot join
- Female patients who are pregnant, lactating, or whom are planning to become pregnant
- Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator)
- Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC).
Trial locations and contacts
49 sites in 8 countries.
49 sites in 8 countries
Germany15 sites
Study site
Berlin
Study site
Bernau
Study site
Bielefeld
Study site
Bonn
Study site
Erlangen
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Heidelberg
Study site
Jena
Study site
Kehl
Study site
Kiel
Study site
Münster
Study site
Stuttgart
Study site
Tübingen
Study site
Vogtareuth
Austria7 sites
Study site
Graz
Study site
Innsbruck
Study site
Linz
Study site
Mödling
Study site
Steyr
Study site
Vienna
Study site
Wein
France7 sites
Study site
Besançon
Study site
Lyon
Study site
Marseille
Study site
Paris
Study site
Reims
Study site
Strasbourg
Study site
Tain-l'Hermitage
Italy6 sites
Study site
Mantua
Study site
Milan
Study site
Padova
Study site
Roma
Study site
Trieste
Study site
Verona
Spain6 sites
Study site
Barcelona
Study site
Córdoba
Study site
Esplugues de Llobregat
Study site
Madrid
Study site
Málaga
Study site
Pamplona
United Kingdom5 sites
Study site
Birmingham
Study site
Cardiff
Study site
London
Study site
Manchester
Study site
West Yorkshire
About this study
Official title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).
This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.
- Conditions
- Lennox-Gastaut Syndrome
- Keywords
- Lennox-Gastaut Syndrome
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rufinamide | Not described | |
| Anti-Epileptic Drugs | Includes those used off label as part of local clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety during the use of rufinamide and other anti-epileptic drugs
Evaluation of the incidence of seizures of medical significance (including status epilepticus, new / worsening of seizure types and withdrawal seizures) during exposure to anti-epileptic drugs, including rufinamide, in patients with LGS; incidence of hypersensitivity reactions during the exposure to anti-epileptic drugs, including rufinamide; common AEs identified with anti-epileptic drugs, as they may be related to this specific population; including sedation, neurological AEs, suicidal-related events, events associated with blood dyscrasias, and the potential increased risk of infections.
Measured: At least three years
Secondary outcomes (1)
Long term use of rufinamide, and other anti-epileptic drugs
Evaluation, within the constraints of this population, of the impact on maturation anddevelopment that anti-epileptic drugs, including rufinamide, has on the LGS population; seizure control in LGS patients, including those taking rufinamide and other anti-epileptic drugs; assessment of healthcare resource utilisation.
Measured: At least three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2008
- Primary completionOct 2015
- Study completionNov 2015
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 Lennox-Gastaut SyndromeStudies of the same condition, open and under way.
- 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991041
- Sponsor's protocol ID
- E2080-E044-401
- Status last verified
- May 2016
- First submitted
- 18 Nov 2013
- Last updated
- 4 May 2016
- Results posted
- No
Publications
Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.
PubMed 28927712
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).
- ClinicalTrials.gov ID
- NCT01991041
- Acronym / sponsor ID
- E2080-E044-401
- Conditions
- Lennox-Gastaut Syndrome
- Keywords
- Lennox-Gastaut Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Nov 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.
This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rufinamide | – | – |
| Anti-Epileptic Drugs | – | –Includes those used off label as part of local clinical practice |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participation in this study will be offered to any patient of four years or older, who has a known diagnosis of LGS, who requires a change in anti-epileptic therapy. This will include patients who are started on rufinamide, as an adjuvant therapy.
Key inclusion criteria (6 listed)
- Patients will be four years and older
- Patients will have an established diagnosis of Lennox-Gastaut syndrome, and:
- Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences)
- Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity)
- Presence of intellectual / learning disability (a variable degree is permitted)
Key exclusion criteria (3 listed)
- Female patients who are pregnant, lactating, or whom are planning to become pregnant
- Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator)
- Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety during the use of rufinamide and other anti-epileptic drugs
Time frame: At least three years
Evaluation of the incidence of seizures of medical significance (including status epilepticus, new / worsening of seizure types and withdrawal seizures) during exposure to anti-epileptic drugs, including rufinamide, in patients with LGS; incidence of hypersensitivity reactions during the exposure to anti-epileptic drugs, including rufinamide; common AEs identified with anti-epileptic drugs, as they may be related to this specific population; including sedation, neurological AEs, suicidal-related events, events associated with blood dyscrasias, and the potential increased risk of infections.
1 secondary outcome
Long term use of rufinamide, and other anti-epileptic drugs
Time frame: At least three 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 4 May 2016.
- Derived from this study: PubMed 28927712Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lennox-Gastaut Syndrome, run by Eisai Limited at 49 sites in 8 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 6 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany, Austria, France, Italy, Spain and 3 more countries. 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?
Safety during the use of rufinamide and other anti-epileptic drugs (time frame: At least three years). 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 NCT01991041, 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 4 May 2016.