A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
NCT ID: NCT01546688
Last Updated: 2016-01-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
41 participants
INTERVENTIONAL
2008-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zonisamide at targeted daily doses of 100-500 mg/day
Zonisamide at targeted daily doses of 100-500 mg/day
Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules
Placebo administered to match daily doses of 100-500 mg/day
Placebo administered to match targeted daily doses of 100-500 mg/day
matching placebo
Interventions
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Zonisamide at targeted daily doses of 100-500 mg/day
Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules
Placebo administered to match targeted daily doses of 100-500 mg/day
matching placebo
Eligibility Criteria
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Inclusion Criteria
2. Able to complete the questionnaires used in this study.
3. Localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the International League Against Epilepsy (ILAE) criteria.
4. Have at least one well documented seizure in the 4 weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
5. Receiving at least one, but not more than two other marketed AEDs as concomitant medication, and the dosage should be stable for at least four weeks before the Screening Visit.
Exclusion Criteria
2. Seizures which could be attributed to use of a drug.
3. Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
4. A history of eating disorders or a body weight below 40 kg.
5. A history of blood dyscrasias.
6. A history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
7. An increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
8. Taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
9. Taking rifampicin or drugs with anticholinergic effects.
10. Taking carbonic anhydrase inhibitors or topiramate.
11. A history of pancreatitis.
12. A history of Stevens Johnson Syndrome.
13. Elevated levels of serum creatinine \>165 Umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
65 Years
ALL
No
Sponsors
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Eisai Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Joanna Segieth
Role: STUDY_DIRECTOR
Eisai Limited
Locations
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Klinik und Polyklinik fur Epileptologie
Bonn, , Germany
Georg-August-Universiat Gottingen
Göttingen, , Germany
Asklepiosklinik Barmbek
Hamburg, , Germany
Clinical Research Hamburg
Hamburg, , Germany
ZNS Hamburg
Hamburg, , Germany
Universitaet Giessen / Marburg
Marburg, , Germany
Neurologische
Siegen, , Germany
Semmelweis University - Neurology Dept.
Budapest, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
National Institute of Neurosurgery
Budapest, , Hungary
County Hospital Kecskemet
Keskemet, , Hungary
B-A-Z County Hospital - Szuleszet-Nogyogyaszat
Miskolc, , Hungary
Sopron Medical SMO
Sopron, , Hungary
County Hospital of Tolna
Szeksz?rd, , Hungary
County Hospital of Zala
Zalaegerszeg, , Hungary
S.C. Neurologia - AO "G.Brotzu"
Cagliari, , Italy
Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi
Florence, , Italy
Dipartimento di Neuroscienze - Universita Federico II
Napoli, , Italy
Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino"
Pavia, , Italy
Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina
Pavia, , Italy
Dip.to Scienze Neurologiche - III Clinica Neurologica
Roma, , Italy
Universita di Torino - Dipt. Neuroscienze
Torino, , Italy
Medisch Centrum Haaglanden - Lokatie Westeinde
VA Den Haag, , Netherlands
Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM'
Kalisz, , Poland
Specjalistyczna Praktyka Lekarska
Katowice, , Poland
NZOZ Centermed Gabinety ?lnolekarskie
Leszno, , Poland
Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki
Lublin, , Poland
Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny
Olsztyn, , Poland
NZOZ Centrum Medyczne HCP
Późna, , Poland
Wielospecjalistyczna Lecznica 'Zycie'
Warsaw, , Poland
Clinical Investigation Unit; Inselspital
Bern, , Switzerland
Spitalzentrum Biel
Biel, , Switzerland
Epilepsie-Zentrum
Zurich, , Switzerland
Whipps Cross university Hospital
London, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
The Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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Other Identifiers
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2006-002516-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2090-E044-402
Identifier Type: -
Identifier Source: org_study_id
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