A more ethical way to compare epilepsy treatments

For the first time, a new research methodology recently approved by the Food and Drug Administration has been used to demonstrate that converting patients from one anti-epileptic drug to another - in this case, lamotrigine extended-release (LTG XR) - is well-tolerated, effective and safe. The work by Jacqueline French and her team, from New York University in the US, illustrates how the new methodology addresses ethical issues inherent in more traditional study designs. It is published online in Springer's journal, Neurotherapeutics.

The use of traditional control groups in experimental designs can raise some ethical concerns, such as using inferior treatments for the control group in the study of an illness with significant morbidity and mortality, such as epilepsy. What French and team have done is compare their - the one where they are moving patients from one drug to another - with a so-called 'historical control group' obtained from a dataset of eight previously published studies, rather than recruit a new control group and give them a potentially less effective drug.

In their study, a total of 226 patients aged 13 years or older undergoing treatment for epilepsy across seven countries were randomly allocated to one of two groups: the first group received LTG XR 250mg; the second received 300mg once daily. During the conversion phase (11-12 weeks), the LTG XR dose was increased progressively as the previous drug was withdrawn gradually. The subjects then had a 12-week maintenance phase with LTG XR as . Throughout the study period, the researchers monitored both the type and frequency of seizures and compared them to pre-intervention assessments.

The results demonstrate that LTG XR is effective as monotherapy. Approximately half of the experienced at least a 50 percent reduction in compared to the number recorded before the study. More than half the group reported minor adverse events, including headache and dizziness predominantly.

The authors conclude: "A conversion-to-monotherapy study like ours, which incorporates a historical control, provides important information to clinicians, who often wish to convert their patients from one anti-epileptic drug to another. Without putting a group of patients at undue risk of seizure worsening, we demonstrated that it is possible to convert patients from another drug to LTG XR and that this conversion is well tolerated."

More information: French J et al (2011). Lamotrigine XR conversion to monotherapy: first study using a historical control group. Neurotherapeutics. DOI 10.1007/s13311-011-0088-3

add to favorites email to friend print save as pdf

Related Stories

New drug may reduce seizures in epilepsy

Apr 13, 2011

A new drug called perampanel appears to significantly reduce seizures in people with hard-to-control epilepsy, according to results of the first clinical trial to test the higher 12 mg dose of the drug. The late-breaking ...

Recommended for you

New learning mechanism for individual nerve cells

5 minutes ago

The traditional view is that learning is based on the strengthening or weakening of the contacts between the nerve cells in the brain. However, this has been challenged by new research findings from Lund University in Sweden. ...

USC memory scientist Richard Thompson dies at 84

16 hours ago

Richard F. Thompson, the University of Southern California neuroscientist whose experiments with rabbits led to breakthrough discoveries on how memories are physically stored in the brain, has died. He was 84.

Modeling shockwaves through the brain

16 hours ago

Since the start of the military conflicts in Iraq and Afghanistan, more than 300,000 soldiers have returned to the United States with traumatic brain injury caused by exposure to bomb blasts—and in particular, ...

User comments