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

January 6, 2016 updated by: Eisai Limited

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • Klinik und Polyklinik fur Epileptologie
      • Gottingen, Germany
        • Georg-August-Universiat Gottingen
      • Hamburg, Germany
        • Clinical Research Hamburg
      • Hamburg, Germany
        • Asklepiosklinik Barmbek
      • Hamburg, Germany
        • ZNS Hamburg
      • Marburg, Germany
        • Universitaet Giessen / Marburg
      • Siegen, Germany
        • Neurologische
  • Hungary
      • Budapest, Hungary, 1145
        • National Institute of Neurosurgery
      • Budapest, Hungary, 1083
        • Semmelweis University - Neurology Dept.
      • Budapest, Hungary, 11036
        • Synexus Magyarorszag Kft.
      • Keskemet, Hungary, 6000
        • County Hospital Kecskemet
      • Miskolc, Hungary, 3501
        • B-A-Z County Hospital - Szuleszet-Nogyogyaszat
      • Sopron, Hungary, 9400
        • Sopron Medical SMO
      • Szeksz?rd, Hungary, 7100
        • County Hospital of Tolna
      • Zalaegerszeg, Hungary, 8900
        • County Hospital of Zala
  • Italy
      • Cagliari, Italy, 00134
        • S.C. Neurologia - AO "G.Brotzu"
      • Firenze, Italy, 50134
        • Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi
      • Napoli, Italy, 80131
        • Dipartimento di Neuroscienze - Universita Federico II
      • Pavia, Italy, 27100
        • Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino"
      • Pavia, Italy, 27100
        • Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina
      • Roma, Italy, 00185
        • Dip.to Scienze Neurologiche - III Clinica Neurologica
      • Torino, Italy, 10126
        • Universita di Torino - Dipt. Neuroscienze
  • Netherlands
      • VA Den Haag, Netherlands, 2512
        • Medisch Centrum Haaglanden - Lokatie Westeinde
  • Poland
      • Kalisz, Poland, 62-800
        • Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM'
      • Katowice, Poland, 40- 097
        • Specjalistyczna Praktyka Lekarska
      • Leszno, Poland, 64-100
        • NZOZ Centermed Gabinety ?lnolekarskie
      • Lublin, Poland, 20-090
        • Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki
      • Olsztyn, Poland, 10-561
        • Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny
      • Pozna, Poland, 61-489
        • NZOZ Centrum Medyczne HCP
      • Warszawa, Poland, 03-464
        • Wielospecjalistyczna Lecznica 'Zycie'
  • Switzerland
      • Bern, Switzerland, 3010
        • Clinical Investigation Unit; Inselspital
      • Biel, Switzerland, 2501
        • Spitalzentrum Biel
      • Zurich, Switzerland, 8008
        • Epilepsie-Zentrum
  • United Kingdom
      • London, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
      • Stoke-on-Trent, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire
      • Truro, United Kingdom, TR1 3LJ
        • The Royal Cornwall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, Week 4, Week 8, Week 12, Week 16
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
The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
Baseline, Week 4, Week 8, Week 12, Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period
Time Frame: Baseline and Month 4
Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.
Baseline and Month 4
Percentage of Responders During Last 28 Days of Maintenance Period
Time Frame: Baseline and Month 4
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.
Baseline and Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joanna Segieth, Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2090-E044-402
  • 2006-002516-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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