A Phase 2 interventional study of Keppra XR in Epilepsy, sponsored by UCB BIOSCIENCES, Inc.. Completed at 6 sites in United States. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by UCB BIOSCIENCES, Inc. · Phase 2, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB BIOSCIENCES, Inc. is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
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Drug: Keppra XR
Drug: Keppra XR
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days
Also known as: Levetiracetam XR
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
The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose. Cmax normalized by 1000 mg dose was calculated as: Cmax/(mg dose taken/ 1000 mg Keppra XR). Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as: Cmax/(bodyweight (kg)/ mg dose Keppra XR taken). Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration.
Time frame: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
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
AUCtau normalized by 1000 mg dose was calculated as: AUCtau/(mg dose taken/ 1000 mg Keppra XR). AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as: AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken). 6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau.
Time frame: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration
The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Time frame: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration
The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Time frame: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.
Time frame: From Starting Study Drug Treatment (Day 1) to up to 14 days
Intent-to-treat (ITT) population includes all enrolled patients who received at least one dose of study medication.Pharmacokinetic Per-Protocol (PK-PP) population is a subset of the ITT population, consisting of those patients who had no major protocol deviations affecting the pharmacokinetic parameters.
| Milestone | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Started | 12 | 13 |
| Pharmacokinetic (pk-pp) population | 12 | 10 |
| Completed | 12 | 13 |
| Not completed | 0 | 0 |
The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose. Cmax normalized by 1000 mg dose was calculated as: Cmax/(mg dose taken/ 1000 mg Keppra XR). Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as: Cmax/(bodyweight (kg)/ mg dose Keppra XR taken). Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration.
| µg/mL | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Dose norm. ( Keppra XR 1000mg) | 17.3 (14.3 to 21.0) | 14.9 (12.1 to 18.5) |
| Dose and weight norm. ( Keppra XR 1 mg/kg) | 1.27 (1.12 to 1.44) | 1.24 (1.08 to 1.42) |
AUCtau normalized by 1000 mg dose was calculated as: AUCtau/(mg dose taken/ 1000 mg Keppra XR). AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as: AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken). 6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau.
| µg*h/mL | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Dose norm. (Keppra XR 1000mg) | 265 (214 to 327) | 236 (187 to 298) |
| Dose and weight norm. (Keppra XR 1 mg/kg) | 19.4 (16.5 to 22.9) | 19.6 (16.4 to 23.5) |
The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
| hours (h) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration | 5.90 (2.50 to 6.07) | 5.93 (2.45 to 6.05) |
The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
| L/h | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration | 3.78 ± 31.4 | 4.23 ± 41.8 |
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.
| Count | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| Total number of AEs | 7 | 11 |
| Patients with at least 1 AE | 3 | 3 |
| Patients with severe AEs | 0 | 1 |
| Patients with serious AEs | 0 | 0 |
Collected over From Starting Study Drug Treatment (Day 1) to up to 14 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Keppra XR in Children (12-16 Years Old) | — | 0/12 (0%) | 3/12 (25%) |
| Keppra XR in Adults (18-55 Years Old) | — | 0/13 (0%) | 3/13 (23.1%) |
| Event | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) |
|---|---|---|
| SomnolenceNervous system disorders | 1/12 | 1/13 |
| NauseaGastrointestinal disorders | 1/12 | 1/13 |
| VomitingGastrointestinal disorders | 1/12 | 1/13 |
| FatigueGeneral disorders | 1/12 | 0/13 |
| LymphadenopathyBlood and lymphatic system disorders | 1/12 | 0/13 |
| Pharyngitis streptococcalInfections and infestations | 1/12 | 0/13 |
| Abnormal behaviourPsychiatric disorders | 1/12 | 0/13 |
| ParaesthesiaNervous system disorders | 0/12 | 1/13 |
| IrritabilityGeneral disorders | 0/12 | 1/13 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/12 | 1/13 |
| Age, Continuous(years) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Mean | 14.88 ± 1.37 | 41.78 ± 9.21 | 28.87 ± 15.21 |
| Sex: Female, Male(Participants) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 6 | 5 | 11 |
| Weight(kilogram (kg)) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Mean | 77.2 ± 24.1 | 82.5 ± 23.0 | 80.0 ± 23.2 |
| Height(centimeter (cm)) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Mean | 165.9 ± 8.8 | 169.3 ± 10.3 | 167.7 ± 9.6 |
| Body Mass Index (BMI)(kg/m^2) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Mean | 27.62 ± 7.01 | 28.63 ± 7.14 | 28.14 ± 6.95 |
| Body Surface Area (BSA)(m^2) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Mean | 1.87 ± 0.34 | 1.95 ± 0.32 | 1.91 ± 0.32 |
| Race(Participants) | Keppra XR in Children (12-16 Years Old) | Keppra XR in Adults (18-55 Years Old) | Total |
|---|---|---|---|
| Black | 4 | 3 | 7 |
| Caucasian | 8 | 9 | 17 |
| Other / mixed | 0 | 1 | 1 |
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