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
This study has been terminated.
Sponsor:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01546688
First received: March 2, 2012
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Zonisamide at targeted daily doses of 100-500 mg/day Drug: Placebo administered to match targeted daily doses of 100-500 mg/day |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Zonisamide
U.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: No ]The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
- Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: No ]The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
Secondary Outcome Measures:
- Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.
- Percentage of Responders During Last 28 Days of Maintenance Period [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.
| Enrollment: | 41 |
| Study Start Date: | November 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Zonisamide at targeted daily doses of 100-500 mg/day |
Drug: 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 Comparator: Placebo administered to match daily doses of 100-500 mg/day |
Drug: Placebo administered to match targeted daily doses of 100-500 mg/day
matching placebo
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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.
- Able to complete the questionnaires used in this study.
- 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.
- 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.
- 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:
- Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
- Seizures which could be attributed to use of a drug.
- Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- A history of eating disorders or a body weight below 40 kg.
- A history of blood dyscrasias.
- A history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
- An increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
- Taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
- Taking rifampicin or drugs with anticholinergic effects.
- Taking carbonic anhydrase inhibitors or topiramate.
- A history of pancreatitis.
- A history of Stevens Johnson Syndrome.
- Elevated levels of serum creatinine >165 Umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546688
Locations
| Germany | |
| Klinik und Polyklinik fur Epileptologie | |
| Bonn, Germany | |
| Georg-August-Universiat Gottingen | |
| Gottingen, Germany | |
| Asklepiosklinik Barmbek | |
| Hamburg, Germany | |
| ZNS Hamburg | |
| Hamburg, Germany | |
| Clinical Research Hamburg | |
| Hamburg, Germany | |
| Universitaet Giessen / Marburg | |
| Marburg, Germany | |
| Neurologische | |
| Siegen, Germany | |
| Hungary | |
| National Institute of Neurosurgery | |
| Budapest, Hungary, 1145 | |
| Semmelweis University - Neurology Dept. | |
| Budapest, Hungary, 1083 | |
| Synexus Magyarorszag Kft. | |
| Budapest, Hungary, 11036 | |
| County Hospital Kecskemet | |
| Keskemet, Hungary, 6000 | |
| B-A-Z County Hospital - Szuleszet-Nogyogyaszat | |
| Miskolc, Hungary, 3501 | |
| Sopron Medical SMO | |
| Sopron, Hungary, 9400 | |
| County Hospital of Tolna | |
| Szeksz?rd, Hungary, 7100 | |
| County Hospital of Zala | |
| Zalaegerszeg, Hungary, 8900 | |
| Italy | |
| S.C. Neurologia - AO "G.Brotzu" | |
| Cagliari, Italy, 00134 | |
| Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi | |
| Firenze, Italy, 50134 | |
| Dipartimento di Neuroscienze - Universita Federico II | |
| Napoli, Italy, 80131 | |
| Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina | |
| Pavia, Italy, 27100 | |
| Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino" | |
| Pavia, Italy, 27100 | |
| Dip.to Scienze Neurologiche - III Clinica Neurologica | |
| Roma, Italy, 00185 | |
| Universita di Torino - Dipt. Neuroscienze | |
| Torino, Italy, 10126 | |
| Netherlands | |
| Medisch Centrum Haaglanden - Lokatie Westeinde | |
| VA Den Haag, Netherlands, 2512 | |
| Poland | |
| Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM' | |
| Kalisz, Poland, 62-800 | |
| Specjalistyczna Praktyka Lekarska | |
| Katowice, Poland, 40- 097 | |
| NZOZ Centermed Gabinety ?lnolekarskie | |
| Leszno, Poland, 64-100 | |
| Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki | |
| Lublin, Poland, 20-090 | |
| Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny | |
| Olsztyn, Poland, 10-561 | |
| NZOZ Centrum Medyczne HCP | |
| Pozna, Poland, 61-489 | |
| Wielospecjalistyczna Lecznica 'Zycie' | |
| Warszawa, Poland, 03-464 | |
| Switzerland | |
| Clinical Investigation Unit; Inselspital | |
| Bern, Switzerland, 3010 | |
| Spitalzentrum Biel | |
| Biel, Switzerland, 2501 | |
| Epilepsie-Zentrum | |
| Zurich, Switzerland, 8008 | |
| United Kingdom | |
| Whipps Cross university Hospital | |
| London, United Kingdom, E11 1NR | |
| University Hospital of North Staffordshire | |
| Stoke-on-Trent, United Kingdom, ST4 7LN | |
| The Royal Cornwall Hospital | |
| Truro, United Kingdom, TR1 3LJ | |
Sponsors and Collaborators
Eisai Limited
Investigators
| Study Director: | Joanna Segieth | Eisai Limited |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Limited ) |
| ClinicalTrials.gov Identifier: | NCT01546688 History of Changes |
| Other Study ID Numbers: | E2090-E044-402 |
| Study First Received: | March 2, 2012 |
| Results First Received: | November 12, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Zonisamide Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013