Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
NCT ID: NCT06392009
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2024-07-10
2026-07-31
Brief Summary
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Detailed Description
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The effects of radiprodil are assessed in participants with treatment-resistant seizures (with or without behavioral symptoms). The daily doses of radiprodil will be individually titrated for every participant and all the participants will receive study drug.
This study is divided into the following periods:
PART A:
* Screening/Observation Period (up to six(6) weeks): Investigators assess eligibility followed by an Observation Period (at least four(4) weeks) to evaluate seizure frequency.
* Titration Period (approx. four(4) weeks): Radiprodil twice daily will be administered in escalating doses and plasma concentrations, safety, and tolerability assessed. Once a safe and potentially effective dose has been established, the participant will immediately enter the Maintenance Period.
* Maintenance Period (approx. twelve(12) weeks): The participant will continue to take the safe and potentially effective dose identified during the Titration Period. At the end of the Maintenance Period the participant will either be invited to enter Part B or the Tapering and Safety Follow-up Period.
* Tapering (15 days) and Safety Follow-up Period (14 days): a participant who doesn't take part in the long-term treatment period (Part B) will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days). In this case, the participant will have one (1) last visit at the end of the safety Follow-up Period.
PART B:
* Long-Term Treatment Period (one(1) year): During the Long-Term Treatment Period (Part B), participants will continue taking radiprodil at the usual dose level and making regular visits to the study site.
* Tapering (15 days) and Safety Follow-up Period (14 days): at the end of the long-term treatment period (Part B), the participant will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days) after his/her last dose of radiprodil. The participant will have one (1) last visit at the end of the safety Follow-up Period.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TSC
Liquid suspension of radiprodil, at concentrations 0.25 mg/mL or 2.50 mg/mL for 1% and 10% formulation respectively. It will be administered twice a day (bid) either orally or via gastric or nasogastric tube.
Radiprodil
Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.
FCD Type II
Liquid suspension of radiprodil, at concentrations 0.25 mg/mL or 2.50 mg/mL for 1% and 10% formulation respectively. It will be administered twice a day (bid) either orally or via gastric or nasogastric tube.
Radiprodil
Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.
Interventions
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Radiprodil
Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
18 Years
ALL
No
Sponsors
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GRIN Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Queensland Children Hospital
South Brisbane, , Australia
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, , Belgium
University Hospitals Leuven, Pediatric Neurology
Leuven, , Belgium
Alberta Children's Hospital
Calgary, , Canada
The Hospital for Sick Children (Sick Kids)
Toronto, , Canada
BC Children's Hospital
Vancouver, , Canada
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy
AOU Meyer
Florence, Tuscany, Italy
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
Countries
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Central Contacts
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Other Identifiers
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2023-506301-20-00
Identifier Type: OTHER
Identifier Source: secondary_id
RAD-GRIN-201
Identifier Type: -
Identifier Source: org_study_id
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