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EpilepsyPhase 3NCT00848549

Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

A Phase 3 study testing Zonisamide and Carbamazepine in people with Epilepsy, run by Eisai Inc. at 133 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Epilepsy
What is being tested?
Zonisamide and Carbamazepine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
133 sitesin 20 countries
Study dates
Oct 2008to Nov 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has completed study E2090-E044-310.
  • Subject is able and willing to give written informed consent.
  • Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects of childbearing potential must be non-pregnant, non-lactating and abide by one of the following medically acceptable contraceptive measures: oral contraceptive pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months, vasectomised partner or abstinence throughout the study and for one month after discontinuation of study medication. When the contraceptive pill is used, this should contain no less than 50 μg oestrogen.
  • The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.

Who cannot join

  • Subject has a history of a significant or currently uncontrolled disease that will contraindicate the use of the study drugs or interfere with the conduct of this study and/or the assessment of safety and efficacy of the study drugs.
  • Subject has a body weight <40 kg.
  • Subject has a newly occurring progressive malignancy during study E2090-E044-310 (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
  • Subject has developed a psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months and is considered uncontrolled; history of suicide attempt, alcohol or drug abuse, chronic treatment with benzodiazepines or barbiturates.
  • Subject is currently taking carbonic anhydrase inhibitors.
  • Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
Show all 9Show fewer
  • Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
  • Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
  • Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.

Trial locations and contacts

133 sites in 20 countries.

133 sites in 20 countries

Poland12 sites

  • Study site

    Gdansk, 80-803

  • Study site

    Gdansk, 80266

  • Study site

    Katowice, 40752

  • Study site

    Krakow, 31-530

  • Study site

    Lodz, 90-153

  • Study site

    Lodz, 93-513

  • Study site

    Lublin, 20-718

  • Study site

    Poznan, 60-355

  • Study site

    Sosnowiec, 41-200

  • Study site

    Szczecin, 71252

  • Study site

    Warsaw, 00-416

  • Study site

    Warsaw, 09-777

Other trials in Poland

Spain11 sites

  • Study site

    Alicante, 03010

  • Study site

    Barcelona, 08041

  • Study site

    Cruces (Vizcaya), 48903

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28047

  • Study site

    Málaga, 29010

  • Study site

    Oviedo, 33006

  • Study site

    Seville, 41009

  • Study site

    Seville, 41013

  • Study site

    Seville, 41014

  • Study site

    Zaragoza, 50009

Other trials in Spain

India10 sites

  • Study site

    Bangalore, 560034

  • Study site

    Bangalore, 560094

  • Study site

    Hyderabad, 500 001

  • Study site

    Koturpuram, Chennai, 600 085

  • Study site

    Madurai, Tamil Nadu, 625 020

  • Study site

    Mumbai, 400 012

  • Study site

    New Delhi, 110 016

  • Study site

    New Delhi, 110 065

  • Study site

    New Delhi, 110095

  • Study site

    Pune, 411 030

Other trials in India

Italy10 sites

  • Study site

    Catanzaro, 88100

  • Study site

    Messina, 98122

  • Study site

    Milan, 20132

  • Study site

    Monza (MI), 20052

  • Study site

    Orbassano, 10043

  • Study site

    Pavia, 27100

  • Study site

    Rome, 00133

  • Study site

    Siena, 53100

  • Study site

    Turin, 10126

  • Study site

    Udine, 33100

Other trials in Italy

Russia10 sites

  • Study site

    Kaliningrad, 236000

  • Study site

    Kazan', 420012

  • Study site

    Madrid, 28038

  • Study site

    Moscow, 117049

  • Study site

    Moscow, 117995

  • Study site

    Moscow, 198103

  • Study site

    Saint Petersburg, 194017

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 197376

  • Study site

    Yaroslavl, 160000

Other trials in Russia

Slovakia9 sites

  • Study site

    Bratislava, 80000

  • Study site

    Bratislava, 826 06

  • Study site

    Bratislava, 833 05

  • Study site

    Brezno, 97701

  • Study site

    Košice, 4190

  • Study site

    NoveZamky, 940 34

  • Study site

    Spitalska 6, 94901

  • Study site

    Vranov nad Topľou, 093 27

  • Study site

    Žilina, 1207

Other trials in Slovakia

Australia8 sites

  • Study site

    Bedford Park, South Australia, 5042

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Heidelberg West, Victoria, 3084

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Queensland, 4558

Other trials in Australia

Hungary8 sites

  • Study site

    Budapest, 1076

  • Study site

    Budapest, 1096

  • Study site

    Budapest, 1145

  • Study site

    Debrecen, 4032

  • Study site

    Gyula, 5700

  • Study site

    Hódmezővásárhely, 6800

  • Study site

    Nyregyhaza, 4400

  • Study site

    Zalaegerszeg-Poozva, 8908

Other trials in Hungary

South Africa8 sites

  • Study site

    Bellair, 4001

  • Study site

    Berea, 4001

  • Study site

    Parktown, 2193

  • Study site

    Pretoria, 0041

  • Study site

    Richards Bay, 3900

  • Study site

    Sandton, 2196

  • Study site

    Tygerberg, 7505

  • Study site

    Umhlanga, 4320

Other trials in South Africa

Greece7 sites

  • Study site

    Athens, 10676

  • Study site

    Athens, 11525

  • Study site

    Athens, 15562

  • Study site

    Pátrai, 26500

  • Study site

    Thessaloniki, 54636

  • Study site

    Thessaloniki, 55236

  • Study site

    Thessaloniki, 57010

Other trials in Greece

Serbia7 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kragujevac, 34000

  • Study site

    Kruševac, 37000

  • Study site

    Niš, 18000

  • Study site

    Novi Sad, 21000

  • Study site

    Sombor, 25000

  • Study site

    Subotica, 24000

Other trials in Serbia

Germany6 sites

  • Study site

    Berlin, 13353

  • Study site

    Bochum, 44805

  • Study site

    Düsseldorf, 40212

  • Study site

    Munich, 81377

  • Study site

    Schwerin, 19053

  • Study site

    Westerstede, 26676

Other trials in Germany

United Kingdom6 sites

  • Study site

    Bristol, BS16 1LE

  • Study site

    Cardiff, CF144XN

  • Study site

    Glasgow, G11 6NT

  • Study site

    Liverpool, L9 7AJ

  • Study site

    Tooting, SW17 0QT

  • Study site

    Treliske, TR1 3LJ

Other trials in United Kingdom

South Korea5 sites

  • Study site

    Anyang, 431-070

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 133-792

  • Study site

    Seoul, 143-729

  • Study site

    Wŏnju, 220-701

Other trials in South Korea

France4 sites

  • Study site

    Béthune, 62408

  • Study site

    Dijon, 21033

  • Study site

    Paris, 75651

  • Study site

    Saint-Etienne, 42055

Other trials in France

Taiwan4 sites

  • Study site

    Changhua, 50006

  • Study site

    Kaohsiung City, 80099

  • Study site

    Taoyuan, 33305

  • Study site

    Yongkang District, 71004

Other trials in Taiwan

Sweden3 sites

  • Study site

    Gothenburg, 41345

  • Study site

    Linköping, SE-58185

  • Study site

    Lund, 22185

Other trials in Sweden

Switzerland3 sites

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Sankt Gallen, 9007

Other trials in Switzerland

Denmark1 site

  • Study site

    Aalborg, 9000

Other trials in Denmark

Montenegro1 site

  • Study site

    Podgorica, 81000

Other trials in Montenegro

About this study

Official title: A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

Conditions
Epilepsy
Being tested
Zonisamide, Carbamazepine
Keywords
Epilepsy, Monotherapy
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZonisamideDrug

    Also called Zonegran

    Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.

  • CarbamazepineDrug

    Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.

Study groups in NCT00848549
Study groupRoleWhat they receive
ZNSActive comparatorNot described
Receives: Drug: Zonisamide
CBZActive comparatorNot described
Receives: Drug: Carbamazepine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Remaining in the Study at Each Visit

    The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.

    Measured: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months

Secondary outcomes (4)

  1. Time to Drop-out Due to Lack of Efficacy

    Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.

    Measured: Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)

  2. Time to Drop-out Due to Adverse Event (AE)

    Adverse events in study subjects included any change in the subject's condition.

    This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).

    Measured: Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)

  3. Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase

    The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.

    Measured: Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)

  4. Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit

    The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.

    Measured: Weeks 0, 26, 52, 78 and 117

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJun 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00848549
Sponsor's protocol ID
E2090-E044-314
Other IDs
2008-001159-23, 2008
Status last verified
Nov 2015
First submitted
19 Feb 2009
Last updated
24 Dec 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zonisamide and Carbamazepine in people with Epilepsy, run by Eisai Inc. at 133 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Poland, Spain, India, Italy, Russia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Remaining in the Study at Each Visit (time frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00848549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

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