Phase 2 Epilepsy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A parent or legal guardian must provide written consent before any study activities begin, and the child must also give their agreement to participate where appropriate for their age and understanding.
- Children who are aged 1 year old up to (but not including) 14 years old at the time consent is signed, of any sex.
- People who have a confirmed genetic change called c.607G>A in the GNAO1 gene, along with both epilepsy and movement disorders as part of their condition.
- People whose seizures have continued despite trying at least two appropriately dosed seizure medications at separate times.
- People whose involuntary movements or dystonic episodes (sudden, severe movement problems) have continued despite trying at least two appropriately dosed medications aimed at controlling those movements.
- Post-menarchal female adolescents (those who have started their period) must have a negative pregnancy test at the start of the study and must agree to use highly effective contraception throughout their participation.
Who may not be able to join:
- People who have another serious medical, neurological, or psychiatric condition, or unstable health, that the trial doctor believes could increase risks or affect the study results.
- People who have an anatomical abnormality, a blood clotting disorder, an active infection, or any other condition that would make it unsafe to receive the study drug through repeated injections into the spine (lumbar punctures).
- People who are pregnant, breastfeeding, or planning to become pregnant during the study.
- People who have received another experimental drug, device, or biological treatment within 1 month before screening, or within 5 half-lives of that product — whichever is the longer period.
- People who have any other disease, condition, or behavioural factor that the trial doctor believes could affect safety, make it difficult to follow the study schedule, or interfere with how the study is conducted or assessed.
- People who are 14 years of age or older.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Elena D Belousova, Prof, Pirogov Russian National Research Medical University
Phone: +7 (499) 487-54-51
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in monthly seizure frequency; Change in total monthly duration of seizures; Change in frequency of non-epileptic hyperkinetic and dystonic episodes; Change in duration of non-epileptic hyperkinetic and dystonic episodes
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.