A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
23. januar 2014 oppdatert av: Eisai Inc.
Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study
The purpose of this study is to evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This is an open labeled non-comparative, multicentric observational post marketing surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monotherapy in patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and tolerability over a 24 weeks treatment period.
This study will include a total of 900 patients with partial, generalized or combined seizures across 30 centres in the country.
The patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval for 24 weeks.
There will be total 7 study visits and the patients will be evaluated for clinically reportable adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for efficacy by evaluation of reduction in seizure frequency as the primary objective of the study.
For secondary objectives the patients data will be evaluated to determine the responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure freedom over the 24 weeks study period.
Studietype
Observasjonsmessig
Registrering (Faktiske)
655
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Delhi, India, 110070
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500016
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Hyderabad, Andhra Pradesh, India, 500027
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Hyderabad, Andhra Pradesh, India, 500057
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Secunderabad, Andhra Pradesh, India, 500003
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Secunderabad, Andhra Pradesh, India, 500015
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Vijaywada, Andhra Pradesh, India
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Vishakapatnam, Andhra Pradesh, India
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Vishakhapatnam, Andhra Pradesh, India, 530002
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Gujarat
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Ahmedabad, Gujarat, India, 380009
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Gujrat
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Ahmedabad, Gujrat, India, 380015
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Karanataka
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Bangalore, Karanataka, India, 560010
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Kerela
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Kochi, Kerela, India, 682012
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Kochi, Kerela, India, 682301
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Maharashtra
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Mumbai, Maharashtra, India, 400012
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Mumbai, Maharashtra, India, 400049
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Pune, Maharashtra, India
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Rajastan
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Jaipur, Rajastan, India, 302004
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Jaipur, Rajastan, India, 302015
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Jaipur, Rajastan, India, 302017
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Tamilnadu
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Chennai, Tamilnadu, India, 500017
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Chennai, Tamilnadu, India, 600006
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Chennai, Tamilnadu, India, 600010
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Chennai, Tamilnadu, India, 600017
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
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Lucknow, Uttar Pradesh, India, 226022
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Noida, Uttar Pradesh, India, 201301
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Single Cohort Study involving community patients with epilepsy
Beskrivelse
Inclusion Criteria:
- Male or female subjects, 18 to 75 years of age inclusive
Treated or untreated subjects suffering from any of the following types of seizures:
- Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures
- Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures
- Combined seizures (mixed)
- Subjects having had a computed tomography (CT) or magnetic resonance imaging (MRI) done within the last upto 10 years that ruled a progressive cause of epilepsy.
- Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible.
- Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and enrollment must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug.
- Patients willing to take the medications as directed, maintain a seizure dairy, report adverse events and willing to come for the follow-ups as per schedule.
- Willing to comply with the protocol requirements.
- Able and willing to give the written informed consent.
Exclusion Criteria:
- Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures.
- Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour).
- Subjects with a history of any significant or currently uncontrolled disease which in the opinion of the investigator will interfere with the conduct of this study or the assessment of safety & efficacy of the study drug.
- Subjects already receiving zonisamide therapy.
- Subjects who have received an investigational new drug or device in the past three months before screening and enrollment.
- Subjects with known hypersensitivity to zonisamide or sulphonamides.
- Subjects with known abnormal renal function (serum creatinine > 1.5 mg/dL) or abnormal hepatic function (Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] > 2 times the upper normal limit).
- Subjects with a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse.
- Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
- Subjects currently taking Mono-Amine Oxidase Inhibitor's (MAO-I's).
- Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Eksperimentell
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zonisamide 100mg tablets
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess safety with zonisamide therapy in adult patients with different seizure types
Tidsramme: 24 weeks
|
24 weeks
|
|
Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Tidsramme: 24 weeks
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Tidsramme: 24 weeks
|
24 weeks
|
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To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Tidsramme: 24 weeks
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24 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Amitabh Dash, Eisai Pharmaceuticals India Private limited
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. januar 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
24. januar 2011
Først innsendt som oppfylte QC-kriteriene
24. januar 2011
Først lagt ut (Anslag)
25. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. januar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EIL/ZONE/CT01/2010
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