Status:
TERMINATED
Buspirone Therapy for Localized Epilepsy
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Anxiety Disorder
Seizures
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Background: Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activ...
Detailed Description
OBJECTIVE: To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the 5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is a 5H...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients may be male or female.
- Patients will be aged 18 65
- Patients must have at least 3 seizures during the one-month baseline.
- Localization-related epilepsy diagnosed by standard clinical criteria that has not responded to treatment with two standard antiepileptic drugs either sequentially or in combination.
- Patients must be able to provide informed consent
- Patients must be able to remain on their baseline AED drugs and doses throughout the study
- Patients must be able to use seizure calendars to record seizures throughout the trial.
- EXCLUSION CRITERIA:
- Pregnant patients will not participate in the study.
- During the study, women of child-bearing potential must use a reliable method of birth control and will have pregnancy testing throughout the protocol.
- Use of any alcohol or recreational drugs starting two weeks before entering baseline and for the duration of the study.
- Patients on medications with potential for a clinically significant interaction with buspirone, including MAO inhibitors, clozapine, zolpidem, hypnotics, hydromorphone derivatives, oxycodone, and diltiazem.
- Current treatment for psychiatric disorder other than depression, anxiety or bipolar disorder.
- Patients with a diagnosis of schizophrenia.
- Current treatment for another significant medical disorder, such as diabetes, or heart disease, or an untreated disorder, that might interfere with the study.
- Calculated Creatinine clearance of less than 80 ml/min calculated with the Cockcroft-Gault formula:
- Clcr = \[(140-age) times ideal body weight in Kg\] times (0.85 if female) divided by (72 times serum Cr in mg/dL)
- Evidence of impaired liver function based on serum chemistries.
- Inability to participate in the study procedures, such as MRI, PET, seizure and adverse event recording, or drug titration
Exclusion
Key Trial Info
Start Date :
November 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01496612
Start Date
November 22 2011
End Date
April 19 2016
Last Update
October 5 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892