New daily pill aims to tame stubborn seizures in tuberous sclerosis
NCT ID NCT07680322
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study tests an oral drug, AV078, in people aged 12 and older with tuberous sclerosis complex (TSC) whose seizures are not controlled by standard medications. Participants are randomly assigned to receive AV078 or a placebo for 12 weeks. The goal is to see if AV078 safely reduces seizure frequency and improves overall symptoms of TSC.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AV078
- What this could lead to
- If it works, AV078 could offer a new daily pill to reduce hard-to-control seizures in people with tuberous sclerosis complex.
- What could go wrong
- This is an early Phase 2 trial with only 42 participants. The drug may not reduce seizures more than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Participants aged 12 years and above. * Diagnosis of TSC based on International TSC Consensus Group criteria. * History of failure to adequately control seizures despite having been treated by two or more regimens of anti-seizure medications (ASMs). * Receiving a stable dose of ASMs for at least 4 weeks at the start of the Screening Period and for the duration of the study. Key Exclusion Criteria: * History of any infection requiring use of antibiotics within the last four weeks. * Current or history of any clinically significant mental or physical illness or condition other than TSC that the Investigator believes would create significant risk for participation in the study. * Recent epilepsy surgery/major surgery or planned surgery during the study. * Treatment with medicines which act in a similar way. * Treatment with medicines that suppress the immune system. * Treatment with medicines that may significantly affect the way the body handles the study drug.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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