A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures. - AZTEC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Male or female patients aged 65 years or over.
2.Patients able and willing to give written informed consent in accordance with ICH GCP guidelines.
3.Patients who are reliable and willing to make themselves available for visits to the Investigator site and study telephone calls.
4.Patients 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.
5.Patients able to complete the questionnaires used in this study.
6.Patients with localisation related epilepsy, with simple and/or complex partial seizures with or without secondary generalised seizures as defined by the International League Against Epilepsy (ILAE) criteria.
7.Patients who have at least one well documented seizure in the four weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
8.Patients will be 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with seizures attributed to metabolic causes (e.g. electrolyte disturbances, hyperglycaemia).
2.Patients with 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.Patients with a history of eating disorders or a body weight below 40 kg.
5.Patients with a history of blood dyscrasias.
6.Patients with a history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
7.Patients with an increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
8.Patients taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
9.Patients taking rifampicin or drugs with anticholinergic effects.
10.Patients taking carbonic anhydrase inhibitors or topiramate.
11.Patients with a history of pancreatitis.
12.Patients with a history of Stevens Johnson Syndrome.
13.Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
14.Patients suffering from clinically significant psychiatric illness, psychological or behavioural problems (e.g. major depressive or bipolar disorder, psychotic disorders, delirium or incapacitating anxiety disorders) or other disorders, which could interfere with study participation.
15.Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
16.Patients with hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
17.Patients considered by the Investigator to be an unsuitable candidate for receiving zonisamide or considered unlikely to comply with the protocol.
18.Any patient who has a contraindication for zonisamide treatment.
19.Treatment with any investigational AED 30 days prior to the Screening Visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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