Phase 2 Epilepsy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Absence Epilepsy (with or without eyelid myoclonia, also called Jeavons Syndrome), or a type of severe epilepsy known as Developmental and Epileptic Encephalopathy (DEE), such as Dravet syndrome, Lennox-Gastaut syndrome, or another form of DEE.
• People with Absence Epilepsy must show at least 4 episodes of a specific brain wave pattern (lasting at least 3 seconds each) on a 24-hour brain activity test (EEG) during the study's baseline period; people with DEE must show a typical brain wave pattern on a routine EEG and have at least 4 seizures during the 4 weeks before the study drug is given.
• People aged 18 to 65 years old (male or female) at the time of the baseline assessment.
• People who have already tried at least one seizure medication at the recommended dose and length of time, and who have been on a stable dose of their current seizure medication(s) for at least 4 weeks before the baseline period, remaining stable throughout the study.
• People who are willing and able to keep a symptom diary, attend study visits, and manage their study medication as required.
• Women who could become pregnant must have a negative pregnancy test at the start of the study; people who could father or become pregnant must be willing to use an accepted form of contraception (including abstinence) during the study and for 90 days after the last dose of the study drug.

Who may not be able to join:

• People who have a current or past history of heart or blood vessel disease, such as heart valve problems, high blood pressure in the lungs, heart attack, stroke, or a significant structural heart condition.
• People with moderate or severe liver problems (those with mild liver abnormalities may be considered on a case-by-case basis after review by the medical team — confirm with trial site).
• People with severely reduced kidney function (confirm with trial site for specific test values).
• People with a significant abnormality in their heart's electrical activity detected on an ECG test (confirm with trial site for specific values).
• People currently taking certain medications, including fenfluramine, lorcaserin, MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants, or other medicines that affect serotonin levels (including certain antipsychotic medications).
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have participated in another clinical trial within the past 30 days (from that study's last scheduled visit); involvement in non-treatment studies will be reviewed by the medical team.
• People with a history of drug or alcohol misuse within the past 12 months, or who return a positive drug screening test (cannabinoids are an exception).
• People who currently have significant thoughts of self-harm or suicide, or who have had a suicide attempt within the past year (assessed using a specific standardised scale — confirm with trial site).
• People who have had, or are currently experiencing, another significant health condition or illness (other than epilepsy) in the 4 weeks before the baseline visit that could affect their safety or ability to take part in the study.

Important: Always verify eligibility with the trial site directly before applying.