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A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II
EU CTIS ID: 2023-506301-20-00
What this study is testing
-To determine the safety and tolerability of multiple individually titrated doses of radiprodil in TSC and FCD Type II patients -To determine the pharmacokinetics (PK) and plasma exposure of radiprodil
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age range: ≥ 6 months up to 18 years at Part A Baseline
- Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriate dosages and durations
- Disease specific criteria: a. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) b. diagnosis of TSC by either clinical or genetic diagnostic criteria (Northrup, 2021) as documented in the participant’s medical record.
- Participant on average has had at least 8 countable motor seizures during a 4 week baseline period with at least 1 seizure occurring in at least 3 of the 4 weeks of Baseline
- All medical interventions for epilepsy / behavior (including ketogenic diet and any neurostimulation devices) should be stable for 28 days prior to Screening with no more than 6 days per month use of rescue medication. Participants should remain on a stable regimen throughout the treatment period.
- Participant’s or their caregivers have signed informed consent and participant has signed assent (if applicable).
You likely can't join if
- Participant with any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to TSC or FCD Type II that would preclude or jeopardize participant’s safe participation or administration of study drug or the conduct of the study according to the judgement of the Investigator.
- Participant with any clinically significant laboratory or ECG abnormalities that according to the Investigator in consultation with the Sponsor would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety data from the participant.
- Participant has severe hepatic dysfunction (Child-Pugh grade C).
- Participant has a history of brain surgery within 6 months of Screening for epilepsy or any other reason.
- Participant with any contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances.
- Participant receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel.
See the full eligibility criteria
Who can join
- Age range: ≥ 6 months up to 18 years at Part A Baseline
- Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriate dosages and durations
- Disease specific criteria: a. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) b. diagnosis of TSC by either clinical or genetic diagnostic criteria (Northrup, 2021) as documented in the participant’s medical record.
- Participant on average has had at least 8 countable motor seizures during a 4 week baseline period with at least 1 seizure occurring in at least 3 of the 4 weeks of Baseline
- All medical interventions for epilepsy / behavior (including ketogenic diet and any neurostimulation devices) should be stable for 28 days prior to Screening with no more than 6 days per month use of rescue medication. Participants should remain on a stable regimen throughout the treatment period.
- Participant’s or their caregivers have signed informed consent and participant has signed assent (if applicable).
- Participant’s or their caregivers are willing and able to complete entries in the eDiary on a daily basis.
- Participant has had an MRI scan within 12 months of the planned date of first dose of study drug.
- Participant is 1 of the following: a. Not of childbearing potential (premenarchal or male/not in possession of a uterus). b. If of childbearing potential (see Section 11.3.4), is nonpregnant (negative serum pregnancy test results at Screening and negative urine pregnancy test results at Baseline), nonlactating, and practicing 1 of the following medically acceptable methods of birth control from Screening through 90 days after the last dose of study drug: • Abstinence as a lifestyle choice. • Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant’s usual menstrual cycle period) before IP administration. • Intrauterine device. c. If male, is willing to use a condom from Screening through 90 days after the last dose of study drug.
What rules you out
- Participant with any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to TSC or FCD Type II that would preclude or jeopardize participant’s safe participation or administration of study drug or the conduct of the study according to the judgement of the Investigator.
- Participant with any clinically significant laboratory or ECG abnormalities that according to the Investigator in consultation with the Sponsor would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety data from the participant.
- Participant has severe hepatic dysfunction (Child-Pugh grade C).
- Participant has a history of brain surgery within 6 months of Screening for epilepsy or any other reason.
- Participant with any contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances.
- Participant receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel.
- Participant has received an investigational treatment within 3 months or 5 half-lives of Screening, whichever is longer.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.