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EpilepsyPhase 3NCT00376766

Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)

A Phase 3 study testing levetiracetam in people with Epilepsy and Drug Resistant, run by University Hospital, Grenoble at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure. Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epilepsy, Drug Resistant
What is being tested?
levetiracetam
How many people
112 participants
Where
10 sitesFrance
Study dates
Feb 2007to Apr 2008
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age from 18 to 65
  • Drug resistant epilepsy, partial seizure
  • Epilepsy diagnosed for more than 2 years
  • Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment
  • Onset of cluster seizure in the 24 hours before enrolment
  • For women : effective contraception
  • Affiliation to the French social security

Who cannot join

  • Inability to tolerate levetiracetam, likely poor compliance
  • Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00.
  • Patient taking 1g/day of levetiracetam with Creatinin clearance < 50ml/min
  • Patient taking 2g/day of levetiracetam with Creatinin clearance < 80ml/min
  • Patient taking more than 2g/day of levetiracetam
  • Hepatic or cardiovascular pathology
Show all 15Show fewer
  • Progressive psychiatric pathology
  • Degenerative neurologic disease
  • Cluster seizure due to an acute symptomatic reason
  • Disorder of consciousness
  • Suspicion of status epilepticus or rapid evolution to status epilepticus
  • Suspicion of psychogenic nonepileptic seizure
  • Pregnant woman or nursing woman
  • Suicidal thoughts
  • Incapacity to give consent, minor patient

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Neurology Department

    Chambéry, Savoie, 73000

  • Neurology department

    Clermont-Ferrand, Puy de Dome, 63003

  • Neurology department

    Grenoble, Isere, 3043

  • Neurology department

    Lille, Nord, 59037

  • Neurology department

    Lyon, Rhone, 69000

  • Neurology department

    Nancy, 54035

  • Neurology department

    Nice, Alpes de Haute provence, 06002

  • Neurology department

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

  • Neurology department

    Strasbourg, 67091

  • Etablissement la Teppe

    Tain-l'Hermitage, Drome, 26600

Other trials in France

About this study

Official title: Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.

This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.

Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.

Read the detailed description

Seizure clustering has been defined as a series of unusual frequency of seizures with return to baseline between events. The most common definition of cluster seizure is three seizures per 24 hours.

The usual treatment of cluster seizure is benzodiazepin. This is recognized efficient therapy but has many side effects. Thus it is important to develop as an new therapeutic to improve patient care. Levetiracetam is an antiepileptic drug used in addition to other antiepileptic drugs with less side effects than benzodiazepin.

The aim of this study is to evaluate the effectiveness and safety of levetiracetam in epilepsy cluster seizure.

This is a double blind, placebo controlled, add-on clinical trial with two phases :

Phase 1 : Double blind phase during 24 hours (H0 to H24). After consent signature and randomization, the patient takes two tablets of levetiracetam or placebo. If the patient has a seizure between H3 and H24, he is considered as a non-respondent patient. If there is a risk of rapid evolution to an statue epilepticus, the investigator can break the blind and adapt the patient treatment accordingly.

Phase 2 : This is an open phase after H24. this phase consists of breaking the blind with free adaption of the therapy by the investigator, and patients follow-up during 1 month.

The randomization is stratify by center. The size of randomization blocks is random because of the systematic breaking blind after 24 hours.

Being tested
levetiracetam
Keywords
Cluster seizure, seizure clustering, repetitive seizure, Drug resistant epilepsy, Levetiracetam, keppra
Medical subject headings
Epilepsy, Drug Resistant Epilepsy

What participants receive

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

  • levetiracetamDrug

What is being measured

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

  1. Ratio of patients who are free of seizure between H3 and H24 in both groups.

Secondary outcomes (6)

  1. Items 1,2,3 of the Clinical Global Impression scale.

  2. Side effects during the study.

  3. Time between H0 and the last seizure.

  4. Type and ratio of epileptic fit between H0 and H24.

  5. Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).

  6. Description of therapeutic adaptation at 1 month after patient enrolment.

Timeline

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

  1. First posted15 Sep 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: recruitment recruitment recruitment recruitment difficulties

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376766
Sponsor's protocol ID
DTCIC 05 24
Status last verified
May 2015
First submitted
14 Sep 2006
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Haut SR, Shinnar S, Moshe SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9. doi: 10.1111/j.0013-9580.2005.29004.x.

    PubMed 15660781

  • Dreifuss FE, Rosman NP, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998 Jun 25;338(26):1869-75. doi: 10.1056/NEJM199806253382602.

    PubMed 9637805

  • Mitchell WG, Conry JA, Crumrine PK, Kriel RL, Cereghino JJ, Groves L, Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999 Nov;40(11):1610-7. doi: 10.1111/j.1528-1157.1999.tb02047.x.

    PubMed 10565590

  • Shorvon SD, Lowenthal A, Janz D, Bielen E, Loiseau P. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia. 2000 Sep;41(9):1179-86. doi: 10.1111/j.1528-1157.2000.tb00323.x.

    PubMed 10999557

  • Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-42. doi: 10.1212/wnl.55.2.236.

    PubMed 10908898

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levetiracetam in people with Epilepsy and Drug Resistant, run by University Hospital, Grenoble at 10 sites in France.

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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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 stopped early (reason given: recruitment recruitment recruitment recruitment difficulties). Results are not available in the source record.

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?

Ratio of patients who are free of seizure between H3 and H24 in both groups.. 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 NCT00376766, which also lists 5 linked publications.

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 28 May 2015.

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