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

NCT01546688 | Terminated Phase 4 Results

• 2 other identifiers: E2090-E044-4022006-002516-10
• Study Type: interventional
• Target: 41
• Locations: 7 countries
• Sites: 36

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).

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period

  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

  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 Outcomes (2)

• Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period

  Baseline and Month 4

• Percentage of Responders During Last 28 Days of Maintenance Period

  Baseline and Month 4

Study Arms (2)

Zonisamide at targeted daily doses of 100-500 mg/day

ACTIVE COMPARATOR

Drug: Zonisamide at targeted daily doses of 100-500 mg/day

Placebo administered to match daily doses of 100-500 mg/day

PLACEBO COMPARATOR

Drug: Placebo administered to match targeted daily doses of 100-500 mg/day

Interventions

Zonisamide at targeted daily doses of 100-500 mg/day DRUG

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

Zonisamide at targeted daily doses of 100-500 mg/day

Placebo administered to match targeted daily doses of 100-500 mg/day DRUG

matching placebo

Placebo administered to match daily doses of 100-500 mg/day

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (36)

Klinik und Polyklinik fur Epileptologie

Bonn, Germany

Location

Georg-August-Universiat Gottingen

Göttingen, Germany

Location

Asklepiosklinik Barmbek

Hamburg, Germany

Location

Clinical Research Hamburg

Hamburg, Germany

Location

ZNS Hamburg

Hamburg, Germany

Location

Universitaet Giessen / Marburg

Marburg, Germany

Location

Neurologische

Siegen, Germany

Location

Semmelweis University - Neurology Dept.

Budapest, 1083, Hungary

Location

Synexus Magyarorszag Kft.

Budapest, 11036, Hungary

Location

National Institute of Neurosurgery

Budapest, 1145, Hungary

Location

County Hospital Kecskemet

Keskemet, 6000, Hungary

Location

B-A-Z County Hospital - Szuleszet-Nogyogyaszat

Miskolc, 3501, Hungary

Location

Sopron Medical SMO

Sopron, 9400, Hungary

Location

County Hospital of Tolna

Szeksz?rd, 7100, Hungary

Location

County Hospital of Zala

Zalaegerszeg, 8900, Hungary

Location

S.C. Neurologia - AO "G.Brotzu"

Cagliari, 00134, Italy

Location

Dip. Di neuroscienze - Centro Epilessie - Osp. Careggi

Florence, 50134, Italy

Location

Dipartimento di Neuroscienze - Universita Federico II

Napoli, 80131, Italy

Location

Centro Epilessia - Istituto Neurologico "Fondazione C. Mondino"

Pavia, 27100, Italy

Location

Centro per la Diagnosi e Cura dell'epilessia - Policlinico Universitario di Messina

Pavia, 27100, Italy

Location

Dip.to Scienze Neurologiche - III Clinica Neurologica

Roma, 00185, Italy

Location

Universita di Torino - Dipt. Neuroscienze

Torino, 10126, Italy

Location

Medisch Centrum Haaglanden - Lokatie Westeinde

VA Den Haag, 2512, Netherlands

Location

Specjalistyczny Zaklad Opieki Zdrowotnej 'KONSYLIUM'

Kalisz, 62-800, Poland

Location

Specjalistyczna Praktyka Lekarska

Katowice, 40- 097, Poland

Location

NZOZ Centermed Gabinety ?lnolekarskie

Leszno, 64-100, Poland

Location

Przych. Specj. I chorob Zaw. Wsi Instytut Medyc. Wsi im. W. Chodzki

Lublin, 20-090, Poland

Location

Oddzia Neurologiczny, Wojewdzki Szpital Specjalistyczny

Olsztyn, 10-561, Poland

Location

NZOZ Centrum Medyczne HCP

Późna, 61-489, Poland

Location

Wielospecjalistyczna Lecznica 'Zycie'

Warsaw, 03-464, Poland

Location

Clinical Investigation Unit; Inselspital

Bern, 3010, Switzerland

Location

Spitalzentrum Biel

Biel, 2501, Switzerland

Location

Epilepsie-Zentrum

Zurich, 8008, Switzerland

Location

Whipps Cross university Hospital

London, E11 1NR, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, ST4 7LN, United Kingdom

Location

The Royal Cornwall Hospital

Truro, TR1 3LJ, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Joanna Segieth

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: August 1, 2011
• Last Updated: January 8, 2016
• Results First Posted: February 6, 2013

Record last verified: 2015-11

Locations

CH (3); DE (7); GB (3); PL (7); HU (8); IT (7); NL (1)