Pediatric Epilepsy Study in Subjects 1-24 Months
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | September 2000 |
| End Date: | June 2006 |
An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with
partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age
who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will
be added to the subject's current epilepsy medications.
partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age
who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will
be added to the subject's current epilepsy medications.
Inclusion criteria:
- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for
LAMICTAL naive subjects as follows:
- A confident diagnosis of epilepsy.
- 4 or more partial seizures per month.
- current treatment with 1 or 2 anti-epileptic drugs.
Exclusion criteria:
- Has seizures not related to epilepsy.
- Has a surgically implanted and functioning vagal nerve stimulator.
- Has previously been treated with lamotrigine.
- Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the
ketogenic diet.
- Use of experimental medication within 30 days of enrollment.
We found this trial at
40
sites
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