A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
26 april 2010 bijgewerkt door: Janssen Cilag Pharmaceutica S.A.C.I., Greece
An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older
The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.
Studie Overzicht
Gedetailleerde beschrijving
Topiramate is a medication that is approved for the treatment of seizures.
In accordance with International guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety.
This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures in adults and in children aged 2 years and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures.
Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician.
Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC).
Patients will be asked to keep a diary of adverse events and seizure activity.
Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators usual standard of care.
At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate.
The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated.
225 adult patients and children aged 2 years or older will be enrolled in the study.
Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the investigator as non-satisfactory.
Observational study - No investigational drug administered.
Studietype
Observationeel
Inschrijving (Werkelijk)
153
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
2 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
225 adult patients and children aged 2 years or older will be enrolled in the study.
Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who should have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the inverstigator as non-satisfactory.
Beschrijving
Inclusion Criteria:
- Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
- History of the type of seizure during the period prior to inclusion in the study and sufficient medical records to document this. Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator
Exclusion Criteria:
- Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
- Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
- Patients with progressive brain tumor or other progressive or degenerative disorders
- Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
- Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
- Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
001
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Individualization of the treatment should begin from 25 mg for 1 week.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
Tijdsspanne: At visit 3-8
|
At visit 3-8
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
Tijdsspanne: Visits:3-8
|
Visits:3-8
|
|
Evaluation of efficacy will be performed with the aid of descriptive statistics.
Tijdsspanne: Visits:3-8
|
Visits:3-8
|
|
Overall assessments of the improvement in the seriousness of seizures will be performed.
Tijdsspanne: Visits:3-8
|
Visits:3-8
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2003
Studie voltooiing (Werkelijk)
1 juni 2005
Studieregistratiedata
Eerst ingediend
24 februari 2006
Eerst ingediend dat voldeed aan de QC-criteria
24 februari 2006
Eerst geplaatst (Schatting)
28 februari 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
27 april 2010
Laatste update ingediend die voldeed aan QC-criteria
26 april 2010
Laatst geverifieerd
1 april 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR003472
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