NCT00376766

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

September 14, 2006

Last Update Submit

May 27, 2015

Conditions

EpilepsyDrug Resistant

Keywords

Cluster seizureseizure clusteringrepetitive seizureDrug resistant epilepsyLevetiracetamkeppra

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

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

  • Side effects during the study.

  • Time between H0 and the last seizure.

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

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

  • +1 more secondary outcomes

Interventions

levetiracetamDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Neurology department

Nice, Alpes de Haute provence, 06002, France

Location

Etablissement la Teppe

Tain-l'Hermitage, Drome, 26600, France

Location

Neurology department

Grenoble, Isere, 3043, France

Location

Neurology department

Lille, Nord, 59037, France

Location

Neurology department

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

Location

Neurology department

Clermont-Ferrand, Puy de Dome, 63003, France

Location

Neurology department

Lyon, Rhone, 69000, France

Location

Neurology Department

Chambéry, Savoie, 73000, France

Location

Neurology department

Nancy, 54035, France

Location

Neurology department

Strasbourg, 67091, France

Location

Related Publications (5)

  • 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.

    PMID: 15660781BACKGROUND

  • 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.

    PMID: 9637805BACKGROUND

  • 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.

    PMID: 10565590BACKGROUND

  • 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.

    PMID: 10999557BACKGROUND

  • 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.

    PMID: 10908898BACKGROUND

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Louis Maillard, Dr

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

  • Serge CHASSAGNON, Dr

    University Hospital of Strasbourg

    PRINCIPAL INVESTIGATOR

  • Cecile SABOURY, Dr

    University Hospital of Strasbourg

    PRINCIPAL INVESTIGATOR

  • Edouard HIRSH, Dr

    University Hospital of Strasbourg

    PRINCIPAL INVESTIGATOR

  • William SZHURAJ, Dr

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

  • Philippe DERAMBURE, Dr

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

  • Jerome PETIT, Dr

    La Teppe Institution

    PRINCIPAL INVESTIGATOR

  • Vincent TAREL, Dr

    Regional Hospital of Chambery

    PRINCIPAL INVESTIGATOR

  • Dominique ROSENBERG, Dr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Helene CATENOIX, Dr

    University Hospital of Lyon

    PRINCIPAL INVESTIGATOR

  • Philippe RYVELIN, Dr

    University Hospital of Lyon

    PRINCIPAL INVESTIGATOR

  • Philippe CONVERS, Dr

    University Hospital of St Etienne

    PRINCIPAL INVESTIGATOR

  • Pierre THOMAS, Dr

    University Hospital of Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

FR(10)