ClinicalTrials.gov record NCT07287202

Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

An Open-Label Phase 1b/2a Study to Evaluate the Safety and Tolerability of Oral SVG103 (Paxalisib) in Adults With Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 65 years old
SexAll
LocationAustralia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label phase 1b/2a study evaluates oral SVG103 (paxalisib) in adults with FCD-II, TSC, or HME. It includes a 4‑week baseline to record seizures, a 12‑week daily treatment phase, and a 4‑week washout; an extension phase may continue treatment for up to 6 additional months. About 12 participants are planned.

What it is studying. The study is testing the safety, tolerability, and pharmacokinetics of daily oral SVG103 (paxalisib). It will also track seizure frequency as a secondary outcome.

What the researchers hope to learn. To evaluate safety, tolerability, and pharmacokinetics of SVG103 (paxalisib) in adults with FCD-II, TSC, or HME, and to measure changes in seizure frequency as a secondary outcome.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SVG103

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participants diagnosed with:
  • FCD-II: diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) or histological/pathological analysis of brain tissue, or
  • TSC: diagnosis of TSC by either clinical or genetic diagnostic criteria as documented in the participant's medical record, or
  • HME: Definitive HME confirmed with MRI.
  • Male or female between the ages of 18 and 65 years of age (inclusive).
  • History of failure to control seizures despite at least 2 ASMs at appropriate dosages and duration of treatment.
  • Participants must have experienced at least 8 countable seizures per month for 2 of the 3 months as documented in historical seizure diaries before the baseline period.
  • If participants are on a ketogenic or modified atkins diet, that the regimen can remain unchanged throughout the study, in the opinion of the investigator.
  • Participants with Neurostimulation devices (i.e. Vagus Nerve Stimulation (VNS), Responsive Neuro Stimulation (RNS), Deep Brain Stimulation (DBS) who meet all of the following conditions:
  • The device has been implanted for ≥1 year prior to the screening visit.
  • The settings must have remained constant for 3 months prior to the screening visit and can remain constant throughout the study, in the opinion of the investigator.
  • The battery is expected to last throughout the study. 8. A participant/caregiver or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
  • Key

Exclusion criteria

  • Clinically significant hepatic, renal, pulmonary, gastrointestinal, neurological (other than epilepsy; HME; TSC; FCD-II), autoimmune, immunological, infections, hematological, malignant conditions that may interfere with or impact the participation in the study or study conduct, as determined but the investigator or sponsor.
  • Immunocompromised participants, defined as acquired immune deficiency syndrome (AIDS), cancer, malnutrition, and certain genetic disorders or undergoing treatment with anticancer drugs, radiation therapy, and stem cell or organ transplant.
  • Participants who have an active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive as evaluated by brain imaging (magnetic resonance imaging [MRI]).
  • Participants being considered for brain surgery during the study or has undergone brain surgery within 6 months prior to screening visit for epilepsy or any other reason.
  • Participants with HbA1c levels ≥9.0%, or with hyperglycemia or diabetes requiring insulin therapy, or significant uncontrolled hyperglycaemia or diabetes mellitus that would compromise patient safety, as determined by the investigator.
  • Participants with active pneumonitis that are clinically symptomatic.
  • Participants with a history of myocardial infarction or coronary artery disease or clinically significant ECG abnormality.
  • Participants who have clinically significant hepatic, renal and blood laboratory values at baseline period.
  • Participants with known sensitivity or allergy to any component in the investigational product(s) (microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and colloidal silicon dioxide).

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is an open-label, phase 1b/2a study to evaluate safety, tolerability, and pharmacokinetics SVG103 (paxalisib) in 12 patients with Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME). The name of the study drug involved in this study is SVG103 (paxalisib). The trial consists of a 4 week prospective baseline period (D-28~D1) to collect seizure data, followed by a 12-week treatment phase. And, there is a 4-week washout (follow-up) phase. It is expected that about 12 participants will take part in this research study for up to 3-4 months as long as there is no serious side effects and disease progression. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved SVG103 (paxalisib) for this specific disease.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would start with a 4‑week baseline period to record seizure activity, then enter a 12‑week treatment phase when you take an oral SVG103 capsule once daily, followed by a 4‑week washout (follow‑up). Participants are randomly assigned to a low‑dose or high‑dose SVG103; the protocol also describes a possible extension of an additional 6 months of treatment. During the study you will keep seizure diaries and be monitored for side effects and adverse events; the study’s outcomes focus on safety, tolerability, pharmacokinetics, and change in seizure frequency. The registry record does not list any invasive procedures (for example lumbar puncture or biopsies) as part of participation.

How the study is structured. This interventional, open-label study assigns participants to one of two daily oral dose levels of SVG103; assignment is randomized and there is no masking. The schedule includes a 4‑week prospective baseline, a 12‑week core treatment phase, and a 4‑week washout; an extension phase may add up to 6 months of treatment. There are two experimental arms (low-dose and high-dose SVG103). Safety and adverse events are measured up to 12 weeks, with seizure diaries used to assess change in seizure frequency.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jul 14, 2026
Primary completion
February 2027 (estimated)
Study completion
March 2027 (estimated)
Target enrollment
12 participants (estimated)
Last updated on registry
Aug 10, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Sovargen

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
screening visit
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
LAR
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
investigational product
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
washout
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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