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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00297349 |
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Date of registration:
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24/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
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Scientific title:
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An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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153 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00297349 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Contacts
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Name:
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Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag Pharmaceutica S.A.C.I. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Non-premenopausal female patients using a medically acceptable contraceptive method
as discussed with their doctor
- History of the type of seizure during the period prior to inclusion in the study and
sufficient medical records to document this. Prior treatment until inclusion in the
study with one or more antiepileptic drug treatment judged non-satisfactory by the
investigator
Exclusion Criteria:
- Patients not suffering from epilepsy, whose seizures are due to other causes
including disease, exposure to harmful substances, active infection or tumor
- Patients with a history of generalized status epilepticus (prolonged seizures) within
the last three months
- Patients with progressive brain tumor or other progressive or degenerative disorders
- Patients with a history (within the previous six months) of mental or emotional
disorders requiring shock treatment or major sedation, monoamine oxidase (MAO)
inhibitors or medications which affect the central nervous system
- Patients with any medical or social condition that may affect their ability to take
part in study or the safety of the study
- Patients who cannot take the drug or fill in the diary, either alone or with help. If
help is needed, it should be permanently available throughout the study
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Seizures
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Intervention(s)
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Drug: Topiramate
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Primary Outcome(s)
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Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
[Time Frame: At visit 3-8]
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Secondary Outcome(s)
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Evaluation of efficacy will be performed with the aid of descriptive statistics.
[Time Frame: Visits:3-8]
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Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
[Time Frame: Visits:3-8]
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Overall assessments of the improvement in the seriousness of seizures will be performed.
[Time Frame: Visits:3-8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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