Keppra has been approved by the U.S. Food and Drug Administration as an add-on treatment for partial, myoclonic, and tonic-clonic seizures in adults and children age 5 and older. Keppra is also used to treat seizures in Dravet syndrome, usually in combination with other anticonvulsant therapies.
How Keppra works
Dravet syndrome is a severe type of epilepsy disorder. Symptoms begin in the first year of life, affecting both the physical health of patients and their development. Most treatments are intended to reduce the severity and frequency of seizures.
The mechanism of action of Keppra is not known, but it is thought to bind to a protein called synaptic vesicle protein 2A (SV2A).
SV2A regulates the release of hormones and signaling molecules in the brain, notably gamma-aminobutyric acid (GABA). GABA reduces the excitability of nerve cells or the signals sent by nerve cells during normal signaling.
Keppra’s binding to SV2A is thought to make it more active, increasing the amount of GABA that is secreted, which reduces or “tunes down” nerve signaling and reduces seizure activity.
Keppra in clinical trials
The effectiveness of Keppra as adjunctive therapy (added to other anticonvulsant medications) was tested in three clinical trials in patients with partial onset seizures who did not respond to anticonvulsant therapy. Trial participants took Keppra in addition to their normal anticonvulsant medication.
In the first trial, adult patients were randomized to one of three groups. Those in the first group (95 patients) received a placebo; patients in the second group (97) received 1,000 mg of Keppra a day; and those in the third group (101 patients) received 3,000 mg of Keppra per day.
Patients received either placebo or Keppra in addition to their other anticonvulsant medications. Patients who received 1,000 mg of Keppra a day showed a 26 percent reduction in their seizure frequency, while those taking 3,000 mg Keppra per day showed a 30 percent reduction in seizure frequency.
In the second trial, adult patients already stably treated with anticonvulsants were also randomized to three groups: 111 patients received placebo; 106 patients received 1,000 mg of Keppra per day, and 105 patients received 2,000 mg of Keppra per day.
Patients were evaluated for three months. Once a baseline seizure frequency was established, patients began receiving treatment, the dose of which was gradually increased over four weeks to the group treatment level. The stable dose was then maintained for three months.
Patients taking 1,000 mg of Keppra had a 17 percent decrease in seizure frequecy, and those on 3,000 mg of Keppra showed a 21 percent reduction in seizure frequency compared to placebo.
The third study included 164 patients, ages 6 and older with generalized epilepsy experiencing primary tonic-clonic seizures. All patients were on a stable dose of one or two anticonvulsant therapies and received either placebo or Keppra at either 3,000 mg per day (adult patients) or 60 mg/kg of body weight per day (for children) in addition to their other treatments.
The placebo-treated group (84 patients) showed a 45 percent decrease in seizure frequency, while the Keppra treated group (80 patients) showed a 78 percent decrease in the number of seizures — a significantly higher reduction than placebo. These results were published in the journal Epilepsy Currents.
Finally, the effects of Keppra were tested in an open-label study in 102 children with refractory seizures, of whom approximately 10 percent were diagnosed with Dravet syndrome.
Patients were first monitored for one month to determine their baseline seizure activity. In the second month, patients were given increasing doses of Keppra at two-week intervals starting at 10 mg/kg of body weight twice a day, then 20 mg/kg twice a day, and finally 40 mg/kg twice a day. This dose was used for the remainder of the study.
The number and severity of the seizures were monitored for the following five months.
The researchers reported that about one-third of the patients responded to treatment with Keppra. Among those who responded, seizure frequency decreased by 66-79 percent.
The researchers noted that Dravet syndrome patients had the lowest response rate of those treated, at around 11 percent. Researchers also noted that age seemed to be predictive of response to Keppra treatment, with younger Dravet patients showing more improvement. The results were published in the scientific journal Seizure.
Keppra may cause side effects, including anger or aggression, anxiety, cough, diarrhea, fever, and headache.
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