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Trial record 19 of 913 for:    "Epilepsy"

Buspirone Therapy for Localized Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Identifier:
First received: December 17, 2011
Last updated: August 9, 2014
Last verified: July 2014


- 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 activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication.


- To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain.


  • Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain.
  • Participants must have tried at least two different antiseizure medications. They must also have had at least three seizures during a 1-month observation period while on current medicines.


  • Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected.
  • Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone.
  • Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples.
  • After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.
  • After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples.
  • After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone.
  • Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.

Condition Intervention Phase
Anxiety Disorder
Partial Epilepsy
Drug: Buspirone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Two Clinical Trial of Buspirone Therapy in Localization-Related Epilepsy

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Difference in seizure rate between the baseline and buspirone periods.

Secondary Outcome Measures:
  • Neuropsychological and mood indices before and three months after starting buspirone

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Buspirone
Detailed Description:


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 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may ameliorate seizures.


Forty patients with localization-related epilepsy


A randomised, double-blind, placebo-controlled cross-over, phase II clinical trial.

The trial will have a screening phase in which each patient will undergo physical and neurological examination, and standard blood tests, followed by a one month baseline phase. At the end of baseline, patients who qualify will have neuropsychological, anxiety, and mood evaluation, FCWAY PET and MRI (if imaging was not performed already). During the subsequent first study phase, patients will be randomized to buspirone or matching placebo. After completion of the first study phase, patients will be crossed over to the alternate study arm. At the end of the study, any patient who wishes to do so may remain on open-label buspirone.


  1. Difference in seizure rate comparing the 3 month placebo and active study phases
  2. Neuropsychological, anxiety, and mood indices comparing the 3 month placebo and active study drug phases

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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.


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01496612

Contact: Patricia M Reeves-Tyer, R. EEG T. (301) 496-1923
Contact: William H Theodore, M.D. (301) 496-1505

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
Principal Investigator: William H Theodore, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Identifier: NCT01496612     History of Changes
Other Study ID Numbers: 120033, 12-N-0033
Study First Received: December 17, 2011
Last Updated: August 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Temporal Lobe Epilepsy
Serotonin 1A Receptor

Additional relevant MeSH terms:
Epilepsies, Partial
Anxiety Disorders
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014