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Zonegran (Zonisamide) - Summary

 
 



ZONEGRAN SUMMARY

ZONEGRAN® (zonisamide) capsules Rx Only

ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents.

ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.


See all Zonegran indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zonegran (Zonisamide)

Epilepsy: pooled data from 17 clinical studies support safety of adjunctive Zonegran® (zonisamide) in children aged six and above
Source: Epilepsy News From Medical News Today [2014.11.13]
The safety profile of adjunctive Zonegran® (zonisamide) in paediatric patients with partial epilepsy is confirmed by pooled data published in the European Journal of Paediatric Neurology(EJPN).

Primary data from Phase 3 study evaluating brivaracetam as adjunctive treatment of partial-onset seizures in epilepsy announced
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.12.11]
UCB has announced the primary efficacy and safety data from the latest Phase 3 study evaluating brivaracetam (fixed doses of 100 and 200 mg/day with no up-titration) as adjunctive treatment in...

Cannabis for Child Seizures: Popular, But Is It Effective?
Source: MedPage Today Neurology [2014.12.10]
(MedPage Today) -- Thus far, only parent reports and open-label trials for support.

Investigational medication used to resolve life-threatening seizures in children
Source: Epilepsy News From Medical News Today [2014.11.17]
In its first clinical application in pediatric patients, an investigational medication developed and manufactured at UC Davis has been found to effectively treat children with life-threatening...

Seizures and migraines in the brain linked
Source: Headache / Migraine News From Medical News Today [2014.11.04]
Seizures and migraines have always been considered separate physiological events in the brain, but now a team of engineers and neuroscientists looking at the brain from a physics viewpoint discovered...

more news >>

Published Studies Related to Zonegran (Zonisamide)

Zonisamide: a review of its use in the management of adults with partial seizures. [2013]
Oral zonisamide (Zonegran(®)) is a benzisoxazole derivative chemically unrelated to other antiepileptic agents. It is indicated in the EU as monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy and as adjunctive therapy to other antiepileptic drugs (AEDs) in the treatment of adults with partial seizures, with or without secondary generalization...

The effect of zonisamide on antipsychotic-associated weight gain in patients with schizophrenia: a randomized, double-blind, placebo-controlled clinical trial. [2013]
CONCLUSION: Zonisamide as an adjuvant treatment is tolerated well and markedly

Zonisamide: its pharmacology, efficacy and safety in clinical trials. [2012]
Zonisamide is a benzisoxazole derivative, chemically unrelated to other antiepileptic drugs, that appears to have multiple mechanisms of action, including inhibition of Na(+) channels and reduction of T-type Ca(2+) currents. It is currently licensed in Europe and the USA for adjunctive treatment of partial seizures in adults, and in Europe as monotherapy for treatment of partial seizures in adults with newly diagnosed epilepsy...

Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. [2011.05.17]
CONCLUSIONS: Pooled treatment algorithm results were not significantly different from olanzapine monotherapy in mitigating weight gain. However, participants who received treatment with metformin with possible progression to amantadine and then zonisamide had significantly less mean weight gain than participants treated with olanzapine alone. Progression of some participants through the algorithm indicated that a single therapy solution may not be adequate for every patient. Patients treated with olanzapine should receive regular weight monitoring. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00401973. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Efficacy and safety of adjunctive zonisamide in adult patients with refractory partial-onset epilepsy: a randomized, double-blind, placebo-controlled trial. [2011]
BACKGROUND AND OBJECTIVE: Clinical studies have reported that zonisamide is effective for a wide range of seizure types, including refractory partial-onset seizures. However, there have been no reported studies of the efficacy of zonisamide in the Chinese population to date. The aim of the present study was to evaluate the efficacy and safety of zonisamide in the treatment of adult Chinese patients with refractory partial-onset epilepsy... CONCLUSION: Zonisamide 300-400 mg/day is effective and well tolerated as an adjunctive drug in adult Chinese patients with refractory partial-onset epilepsy.

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Clinical Trials Related to Zonegran (Zonisamide)

Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial [Active, not recruiting]
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg

- 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a

body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.

Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug [Recruiting]
An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.

Fed Study of Zonisamide Capsules 100 mg and Zonegran« Capsules 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran« 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.

Fasting Study of Zonisamide Capsules 100 mg and Zonegran« Capsules 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran« 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation [Recruiting]
About 20. 6 % of the US population smokes cigarettes. This group includes nicotine dependent smokers who are resistant to current smoking cessation treatments. Varenicline is a smoking cessation medication found in meta-analytic reviews to be superior to other smoking cessation treatments, but 56% of patients who take varenicline do not quit. One strategy to increase quit rates may be to administer a second medication to augment the efficacy of varenicline. The anti-epileptic medication zonisamide is a good candidate for adjunct treatment as it increases dopaminergic tone, normalizes glutamate homeostasis, potentiates GABA release. Zonisamide improves sleep and promotes weight loss, two prominent issues not addressed by varenicline. Finally, the PI of this proposal has documented unpleasant changes in the taste of cigarettes and reductions in nicotine withdrawal among smokers receiving zonisamide as part of another clinical trial. The proposed study will explore the efficacy of varenicline + zonisamide for smoking cessation in a controlled, clinical trial. Eligible participants (n=60) will be smokers (>10 cig/day for >1 year) seeking treatment. They will be randomly assigned to receive varenicline + double-blind zonisamide or placebo for a 10-weeks. Participants will visit the clinic weekly to receive medications and smoking cessation counseling and to complete self-report questionnaires. Smoking status will be assessed via weekly urinalysis testing for cotinine (abstinence: <200ng/ml). Cotinine is a sensitive indicator of smoking status with a longer half-life then carbon monoxide (CO) and is more likely to detect low or intermittent smoking. The study hypothesis is that participants who receive the combination zonisamide + varenicline will achieve greater smoking abstinence compared to varenicline alone. The primary outcome measure will be the 4-week rate of biochemically-confirmed continuous smoking abstinence during weeks 7-10. Secondary outcomes will include self-reported rates of smoking, subjective effects of cigarettes, weight change from baseline to week 10, sleep quality, and nicotine withdrawal severity. This study will advance the science and clinical treatment of smoking cessation, and will provide the prerequisite data to develop a larger scale clinical trial evaluation of the combination zonisamide + varenicline for smoking cessation.

more trials >>

Reports of Suspected Zonegran (Zonisamide) Side Effects

Rash (11)Convulsion (11)Agitation (8)Foetal Exposure During Pregnancy (6)Drug Interaction (6)Fatigue (6)Confusional State (5)Drug Ineffective (5)Chest Pain (5)Vomiting (5)more >>


Page last updated: 2014-12-11

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