Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01128712
Eligibility Criteria:
Inclusion Criteria
* An IRB-approved consent form signed and dated by the subject
* A diagnosis of partial epilepsy which is drug resistant according to the International League Against Epilepsy criteria (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom). Furthermore to meet the ILAE definition of drug resistance, subjects will have had breakthrough seizures occurring at a frequency of less than 3 times the longest pretreatment interseizure interval or every 12 months, which ever is longer.
* Subjects that score ≥18 on Beck Anxiety Inventory will be included in the study
* Subjects from 18 to 75 years, both inclusive.
* Females without childbearing potential or childbearing potential using medically accepted forms of birth control (pre-menarcheal, post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy, or medically accepted form of contraception).
* Subject judged by the Investigator to be reliable and capable of adhering to the protocol, visit schedules, and able to understand and complete study instruments.
* CT or MRI scan performed within 2 years of screening and without evidence of a progressive lesion or neurological condition.
* Electroencephalogram consistent with partial epilepsy and does not demonstrate generalized spike wave.
* Currently treated with a stable dose of 1-2 AEDs for a minimum of 4 weeks (3 months for phenobarbital and primidone). Benzodiazepines used as a rescue therapy for seizures and used no more than once a week will be permitted.
Exclusion Criteria
* History of psychogenic non-epileptic seizures.
* The subject is pregnant or lactating.
* Women with reproductive potential who refuse to use medically accepted forms of birth control.
* Presence of any clinically significant laboratory abnormality which in the judgement of the investigator should exclude the subject from the study.
* Presence of any progressive, demyelinating, or degenerative neurological condition.
* Subject is currently taking gabapentin.
* History of an allergic reaction to gabapentin or PGB.
* History of worsened seizures or serious adverse reactions to gabapentin.
* History of suicide attempt.
* No active suicidal plan/intent or active suicidal thoughts in the last 6 months.
* Current use or use within the previous three months prior to screening of antidepressant, anxiolytic, or antipsychotic agents. Subjects using benzodiazepines for anxiety will not be permitted.
* Diagnosis of Bipolar Disorder, Schizophrenia, psychotic disorder (excluding post-ictal psychosis), Major Depression requiring hospitalization in the past 2 years, or other psychological or behavioral condition which in the judgement of the investigator should exclude the subject from the study.
* A history of alcoholism, drug abuse, or drug addiction within the last 2 years.
* Any contraindication to use of PGB.
* Any clinical condition (e.g. severe renal impairment, chronic hepatic disease, serious infection, and or bone marrow depression) which will impair participation in the trial.
* History of multiple drug allergies or severe drug allergy.
* Subjects with vagal nerve stimulators (VNS).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01128712
Study Brief:
Protocol Section:
NCT01128712