Clinical trial NCT01546688: 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
Official title: A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).


Eligibility criteria: Key Inclusion Criteria:

1. Capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf.
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.

Key Exclusion Criteria:

1. Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
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.

Primary outcomes:
measure: Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
Secondary outcomes:
measure: Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period
timeFrame: Baseline and Month 4
measure: Percentage of Responders During Last 28 Days of Maintenance Period
timeFrame: Baseline and Month 4
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Klinik und Polyklinik fur Epileptologie
city: Gottingen
country: Germany
facility: Georg-August-Universiat Gottingen
city: Hamburg
country: Germany
facility: Asklepiosklinik Barmbek
city: Hamburg
country: Germany
facility: Clinical Research Hamburg
city: Hamburg
country: Germany
facility: ZNS Hamburg
city: Marburg
country: Germany
facility: Universitaet Giessen / Marburg
city: Siegen
country: Germany
facility: Neurologische
city: Budapest
country: Hungary
facility: Semmelweis University - Neurology Dept.
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Budapest
country: Hungary
facility: National Institute of Neurosurgery
city: Keskemet
country: Hungary
facility: County Hospital Kecskemet
city: Miskolc
country: Hungary
facility: B-A-Z County Hospital - Szuleszet-Nogyogyaszat
city: Sopron
country: Hungary
facility: Sopron Medical SMO
city: Szeksz?rd
country: Hungary
facility: County Hospital of Tolna
city: Zalaegerszeg
country: Hungary
facility: County Hospital of Zala
city: Cagliari
country: Italy
facility: S.C. Neurologia - AO "G.Brotzu"
city: Firenze
country: Italy
facility: Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi
city: Napoli
country: Italy
facility: Dipartimento di Neuroscienze - Universita Federico II
city: Pavia
country: Italy
facility: Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino"
city: Pavia
country: Italy
facility: Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina
city: Roma
country: Italy
facility: Dip.to Scienze Neurologiche - III Clinica Neurologica
city: Torino
country: Italy
facility: Universita di Torino - Dipt. Neuroscienze
city: VA Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden - Lokatie Westeinde
city: Kalisz
country: Poland
facility: Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM'
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Leszno
country: Poland
facility: NZOZ Centermed Gabinety ?lnolekarskie
city: Lublin
country: Poland
facility: Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki
city: Olsztyn
country: Poland
facility: Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny
city: Pozna
country: Poland
facility: NZOZ Centrum Medyczne HCP
city: Warszawa
country: Poland
facility: Wielospecjalistyczna Lecznica 'Zycie'
city: Bern
country: Switzerland
facility: Clinical Investigation Unit; Inselspital
city: Biel
country: Switzerland
facility: Spitalzentrum Biel
city: Zurich
country: Switzerland
facility: Epilepsie-Zentrum
city: London
country: United Kingdom
facility: Whipps Cross university Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
Study officials:
affiliation: Eisai Limited
name: Joanna Segieth
role: STUDY_DIRECTOR
References: