|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00659958 |
|
Date of registration:
|
16/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
|
|
Scientific 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 |
|
Date of first enrolment:
|
April 2008 |
|
Target sample size:
|
32 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00659958 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Jesus De Rosendo |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
EISAI Farmaceutica S.A. Head of Medical Department |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
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.
Exclusion Criteria:
Those who do not fulfill the Inclusion requirements.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Epilepsy
|
|
Intervention(s)
|
|
Drug: Zonisamide
|
|
Primary Outcome(s)
|
|
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.]
|
|
Secondary Outcome(s)
|
|
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.]
|
|
Secondary ID(s)
|
|
E2090-E044-407
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|