Phase 2
Completed N=25
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Source: ClinicalTrials.gov NCT00961441 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration — 17.3; 14.9; 1.27; 1.24 µg/mL
Summary
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration |
17.3; 14.9; 1.27; 1.24 | — |
| PRIMARY Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration |
265; 236; 19.4; 19.6 | — |
| PRIMARY Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration |
5.90; 5.93 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration |
3.78; 4.23 | — |
| SECONDARY Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days |
7; 11; 3; 3; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs
- Subjects on levetiracetam immediate release (IR) can be enrolled if on a stable dose for 7 days
Exclusion Criteria
- Subjects with a history of status epilepticus within 3 months of Visit 1
- Subject has difficult venous accessibility
Data sourced from ClinicalTrials.gov (NCT00961441). 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.