PRX-00023 Therapy in Localization-Related Epilepsy
Status:
Terminated
Trial end date:
2017-10-05
Target enrollment:
Participant gender:
Summary
Background:
- The brain chemical serotonin helps nerve cells communicate. Previous research suggests that
serotonin activity may be lower in brain areas where seizures start, and that increasing
activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers
are interested in determining whether the experimental medication PRX-00023, which increases
the activity of serotonin receptors, can reduce seizure frequency in people whose seizures
are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied
in people with epilepsy and has not previously been given to people taking antiseizure
medication at the same time.
Objectives:
- To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures
that start from only one part of the brain.
Eligibility:
- Individuals between 18 and 65 years of age who have frequent epileptic seizures even after
trying at least two different standard anti-seizure medications (either at the same time or
one after the other).
Design:
- The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period.
Individuals who choose to participate in additional studies may be an inpatient during
some of these visits.
- Participants will be screened with a medical history and physical examination, blood and
urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and
MRI scans
- Participants will have a 6-week observation and evaluation period before starting the
study medication. Participants who have at least four seizures during this period will
be eligible for the treatment portion of the study.
- All participants will receive either PRX-00023 or a placebo pill twice daily for 12
weeks, and will have regular clinic visits with blood samples and imaging studies.
- After the 12-week period, participants will have a 2- to 3-week washout period without
any study medication.
- Participants will then have another study medication period, and will receive the
opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase.
Participants will continue to have regular clinic visits with blood samples, ECG, EEG
and neuropsychologicalstudies.
- One month after the end of the second study medication phase, participants will have a
followup evaluation with a physical examination, blood tests, ECG, EEG, mood and
neuropsychological tests.
Outcome measures:
The primary outcome measure for drug efficacy will be:
Mean difference in seizure frequency comparing the active and placebo periods.
Secondary outcome measures for efficacy will be:
Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than
placebo
Hamilton Depression and Anxiety Rating scales
Performance on mood and neuropsychological testing scales
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)