N/A
Completed N=101
Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
Source: ClinicalTrials.gov NCT01210690 ↗Enrolled (actual)
101
Serious AEs
31.7%
Results posted
Nov 2014
Primary outcomePrimary: Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit — 55 participants
Summary
The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit |
55 | — |
| SECONDARY Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up |
32 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit |
5 | — |
| SECONDARY Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit |
54; 52; 48; 48 | — |
| SECONDARY Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit |
0.740 | — |
| SECONDARY Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit |
0.335 | — |
| SECONDARY Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit |
-0.307 | — |
| SECONDARY Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit |
— | — |
| SECONDARY Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit |
— | — |
| SECONDARY Global Evaluation Scale of the Psychomotor Development (GES) |
45; 31; 9 | — |
| SECONDARY Global Evaluation Scale of Epilepsy Severity (GES) |
61; 16; 8 | — |
| SECONDARY Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period |
12 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of epilepsy
- being treated with Keppra® Oral Solution
- aged between 1 month and 11 months inclusive at study baseline
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT01210690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.