Focal Cortical DysplasiaPhase 1/2NCT07287202
Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)
A Phase 1/2 study testing SVG103 in people with Focal Cortical Dysplasia and Tuberous Sclerosis Complex (TSC), run by Sovargen at 2 sites in Australia.
Trial summary
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC), Hemimegalencephaly
- What is being tested?
- SVG103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesAustralia
- Study dates
- 14 Jul 2026to Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 6. 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.
- 7. 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
Epilepsy Research Centre, +61 03 9035 7361, erc-trials@unimelb.edu.au
- Recruiting
The Alfred
Melbourne, Victoria, 3004
Alfred Neuroscience Clinical Trials Unit, +61 03 9076 2029, neurologyclinicaltrials@alfred.org.au
About this study
Official title: 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)
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Read the detailed description
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.
- Being tested
- SVG103
- Keywords
- FCD-II, TSC, HME
- Medical subject headings
- Focal Cortical Dysplasia, Tuberous Sclerosis, Hemimegalencephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVG103Drug
Also called paxalisib
The study treatment is administered for 3 months during the core phase and for an additional 6 months during the extension phase. Oral, daily, dosage per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Drug: SVG103 capsule (low-dose) It will be administered once a day (q.d.) orally. Receives: Drug: SVG103 |
| Arm2 | Experimental | Drug: SVG103 capsule (high-dose) It will be administered once a day (q.d.) orally. Receives: Drug: SVG103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Adverse Drug Reactions (ADRs), TEAEs Leading to Discontinuation and Severity of TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical study patient, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event was any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other event that requires scientific judgment.
Measured: Up to 12 Weeks
Secondary outcomes (1)
Change from baseline in seizure frequency
Assessed by seizure diaries
Measured: Baseline (week 1) to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start14 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Cortical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sovargen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287202
- Sponsor's protocol ID
- SVG103-001
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07287202
- Acronym / sponsor ID
- SVG103-001
- Keywords
- FCD-II, TSC, HME
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SovargenIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: SVG103Drug: SVG103 capsule (low-dose) It will be administered once a day (q.d.) orally. |
| Arm2 | Experimental | Drug: SVG103Drug: SVG103 capsule (high-dose) It will be administered once a day (q.d.) orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants diagnosed with:
- 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.
- 6. 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVG103Also: paxalisibThe study treatment is administered for 3 months during the core phase and for an additional 6 months during the extension phase. Oral, daily, dosage per protocol. | Drug | Arm1, Arm2 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Adverse Drug Reactions (ADRs), TEAEs Leading to Discontinuation and Severity of TEAEs
Time frame: Up to 12 Weeks
An adverse event (AE) was any untoward medical occurrence in a clinical study patient, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event was any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other event that requires scientific judgment.
1 secondary outcome
Change from baseline in seizure frequency
Time frame: Baseline (week 1) to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SVG103 in people with Focal Cortical Dysplasia and Tuberous Sclerosis Complex (TSC), run by Sovargen at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Adverse Drug Reactions (ADRs), TEAEs Leading to Discontinuation and Severity of TEAEs (time frame: Up to 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.