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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00376766
• Other study ID #: DTCIC 05 24
• Status: Terminated
• Phase: Phase 3
• First received: September 14, 2006
• Last updated: May 27, 2015
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Resistant
• Epilepsy
• Seizures

Intervention

Drug:
• levetiracetam

Locations

Country	Name	City	State
France	Neurology Department	Chambery	Savoie
France	Neurology department	Clermont-Ferrand	Puy de Dome
France	Neurology department	Grenoble	Isere
France	Neurology department	Lille	Nord
France	Neurology department	Lyon	Rhone
France	Neurology department	Nancy
France	Neurology department	Nice	Alpes de Haute provence
France	Neurology department	St Etienne	Loire
France	Neurology department	Strasbourg
France	Etablissement la Teppe	Tain l'Hermitage	Drome

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France, UCB Pharma

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

Haut SR, Shinnar S, Moshé SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9. — View Citation

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. — View Citation

Shorvon SD, Löwenthal 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of patients who are free of seizure between H3 and H24 in both groups.
Secondary	Items 1,2,3 of the Clinical Global Impression scale.
Secondary	Side effects during the study.
Secondary	Time between H0 and the last seizure.
Secondary	Type and ratio of epileptic fit between H0 and H24.
Secondary	Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).
Secondary	Description of therapeutic adaptation at 1 month after patient enrolment.