Clinical Trials in Spain / NCT06392009
Active, not recruiting
Phase 1/2
Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
NCT06392009 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Tuberous Sclerosis ComplexFocal Cortical Dysplasia
Investigational drug(s) / intervention(s)
Radiprodil: Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.
Study summary
Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.
Eligibility
Inclusion Criteria:
* Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriate dosages and duration
* Disease specific criteria:
1. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI)
2. 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/witnessed primary 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 must remain on a stable regimen throughout the treatment period
* Participant has had an MRI scan within 12 months of the planned date of first dose of study drug
Exclusion Criteria:
* 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.
* Clinically significant laboratory or ECG abnormalities.
* Severe hepatic dysfunction (Child-Pugh grade C).
* History of brain surgery within 6 months of screening for epilepsy or any other reason.
* Contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances.
* Receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel.
* body weight \<10kg for whom a gastric tube is the only possibility for radiprodil dosing.
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Adverse Drug Reactions (ADRs), TEAEs Leading to Discontinuation and Severity of TEAEs — from Baseline to End-of-study: 1 year 6 months
Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions. - Plasma concentration of radiprodil and maximum plasma concentration (Cmax) — Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
- Plasma concentration of radiprodil versus time, area under the curve (AUCt) — Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
- Pharmacokinetic plasma concentration of radiprodil: half-life (T1/2) — Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
- Pharmacokinetic plasma concentration of radiprodil: time to Cmax (Tmax) — Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
- Pharmacokinetic plasma concentration of radiprodil, clearance (Cl) — Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
- Number of participants with abnormal laboratory tests results — from Baseline to End-of-study: 1 year 6 months
The clinical laboratory tests include Hematology, Serum Chemistry and Coagulation - Number of participants with abnormal physical and neurological examination findings — Baseline, MV7, and in Part B: Month 3, 6, 9, 12: week 6, week 28, week 40, week 52, week 64, week 76
A complete physical and neurological examination according to standard of care excluding the genitourinary examination will be performed - Clinically relevant changes in safety parameters: systolic blood pressure — from Baseline to End-of-study: 1 year 6 months
changes from Baseline to End of study for systolic blood pressure - Clinically relevant changes in safety parameters: diastolic blood pressure — from Baseline to End-of-study: 1 year 6 months
changes from Baseline to End of study for diastolic blood pressure - Clinically relevant changes in safety parameters: pulse rate — from Baseline to End-of-study: 1 year 6 months
changes from Baseline to End of Treatment for pulse rate - 12-Lead ECG: Mean change from Baseline to End-of-Treatment in RR interval — from Baseline to End-of-study: 1 year 6 months
- 12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval — from Baseline to End-of-study: 1 year 6 months
- 12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval — from Baseline to End-of-study: 1 year 6 months
- 12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval — from Baseline to End-of-study: 1 year 6 months
- 12-Lead ECG: Mean change from Baseline to End-of-Treatment in QTcF interval — from Baseline to End-of-study: 1 year 6 months
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Queensland Children Hospital | South Brisbane | Australia | |
| University Hospitals Leuven, Pediatric Neurology | Leuven | Belgium | |
| Alberta Children's Hospital | Calgary | Canada | |
| The Hospital for Sick Children (Sick Kids) | Toronto | Canada | |
| IRCCS Istituto Giannina Gaslini | Genoa | Liguria | |
| AOU Meyer | Florence | Tuscany | |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) | Roma | Italy | |
| Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli" | Roma | Italy | |
| UMC Uthrecht - Wilhelmina Kinderziekenhuis | Utrecht | Netherlands | |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | |
| Centrum Medyczne Plejady | Krakow | Poland | |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | |
| Instytut Pomnik - Centrum Zdrowia Dziecka | Warsaw | Poland | |
| Hospital Universitario Vall D´Hebrón | Barcelona | Spain | |
| Hospital Materno Infantil Sant Joan de Deu de Barcelona | Barcelona | Spain | |
| Hospital Universitario Vithas La Milagrosa | Madrid | Spain | |
| Hospital Ruber Internacional | Madrid | Spain | |
| University Hospitals Bristol and Weston NHS Foundation Trust Bristol Royal Hospital for Children | Bristol | United Kingdom |
More GRIN Therapeutics, Inc. trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06392009 on ClinicalTrials.gov ↗ ← All trials in Spain