EpilepsyPhase 4NCT00659958
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
A Phase 4 study testing Zonisamide in people with Epilepsy, run by Eisai Inc. at 11 sites in Spain.
Trial summary
The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonisamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesSpain
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included.
Who cannot join
- Those who do not fulfill the Inclusion requirements.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Complejo Hospitalario Universitario 'Juan Canalejo'
A Coruña, Galicia, 15006
C.H. A. Marcide Profesor Novoa Santos
Ferrol, Galicia, 15405
Centro Sanitario Complexo Hospitalario "XERAL-CALDE"
Lugo, Galicia, 27004
Hospital Comarcal de Monforte
Lugo, Galicia, 27400
Centro Sanitario Hospital Da Costa de Burela
Lugo, Galicia, 27880
Complejo Hospitalario de Ourense
Ourense, Galicia, 32005
Complejo Hospitalario de Pontevedra
Pontevedra, Galicia, 36071
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, Galicia, 15706
Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro
Vigo, Galicia, 36204
Hospital Povisa
Vigo, Galicia, 36211
Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies
Vigo, Galicia, 63204
About this study
Official title: Post-authorization, Observational and Prospective Follow up Study to Evaluate Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs.
Read the detailed description
Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed consent, will be included in the study.
To these patients, physicians will prescribe zonisamide in the following manner: Titration period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable.
Drugs will be prescribed by the physician and purchased by the patient.
- Conditions
- Epilepsy
- Being tested
- Zonisamide
- Keywords
- zonisamide, partial onset seizures, effectiveness, tolerability
- 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
300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of seizures.
Measured: Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.
Secondary outcomes (1)
Quality of life, tolerability.
Measured: Quality of Life evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks have passed. Tolerability will be assessed at the beginning of the study (enrollment visit) and at 12, 18, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Farmacêutica S.A.
- Responsible party
- Sponsor
- Investigators
- Jesus De Rosendo, Study chair, EISAI Farmaceutica S.A. Head of Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659958
- Sponsor's protocol ID
- E2090-E044-407
- Status last verified
- Mar 2010
- First submitted
- 16 Apr 2008
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-authorization, Observational and Prospective Follow up Study to Evaluate Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
- ClinicalTrials.gov ID
- NCT00659958
- Acronym / sponsor ID
- E2090-E044-407
- Conditions
- Epilepsy
- Keywords
- zonisamide, partial onset seizures, effectiveness, tolerability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Farmacêutica S.A.
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs.
Detailed description
Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed consent, will be included in the study.
To these patients, physicians will prescribe zonisamide in the following manner: Titration period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable.
Drugs will be prescribed by the physician and purchased by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zonisamide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included.
Key exclusion criteria (1 listed)
- Those who do not fulfill the Inclusion requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZonisamideAlso: Zonegran300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. | Drug | 1 |
Primary outcome
Frequency of seizures.
Time frame: Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.
1 secondary outcome
Quality of life, tolerability.
Time frame: Quality of Life evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks have passed. Tolerability will be assessed at the beginning of the study (enrollment visit) and at 12, 18, and 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus De Rosendo study chair
EISAI Farmaceutica S.A. Head of Medical Department
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zonisamide in people with Epilepsy, run by Eisai Inc. at 11 sites in Spain.
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 1 inclusion and 1 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of seizures. (time frame: Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2013.