GRIN Therapeutics
GRIN Therapeutics Trial on the Safety and Efficacy of Radiprodil
HONEYCOMB TRIAL UPDATE
Radiprodil reduces seizures in GRIN (Gain-of-Function) patients by a median of 86% in first-ever commercial clinical trial for GRI Disorders
Radioprodil reduced seizures among people with gain-of-function GRIN Disorders by a median of 86% in a Phase 1B clinical trial, according to GRIN Therapeutics.
The potential treatment also led to clinical improvements in other symptoms, and was well tolerated from a safety perspective.
While there’s still a long road before regulators would even consider approving Radiprodil as a treatment for people living with GRI Disorder, these results mark a significant milestone in efforts to find treatments and cures for people living with GRI Disorders.
GRIN Therapeutics said 15 people were part of its Phase 1B trial. Everyone in the trial had a gain-of-function GRIN variant – a mix of GRIN1, GRIN2A and GRIN2B Disorders.
Eight of the study participants experienced regular seizures before the trial. But after taking Radiprodil in the trial, seizures were reduced by a median of 86%. This means that four participants saw a reduction of greater than 86% while four saw a reduction of less than 86%. Only one person stopped seizing altogether, but nearly half (43%) saw seizures drop by at least 90%.
Among the broader group of 15 people enrolled in the study, parents and doctors “generally assessed patients as clinically improved” in non-seizure measures, GRIN Therapeutics said.
Dr. Bruce Leuchter, President and Chief Executive Officer at Neurvati Neurosciences and GRIN Therapeutics said the results “provide strong rationale” to move Radiprodil to a Phase 3 clinical trial as quickly as possible.
Check out our blog post to learn more!Clinical Trial Update – Honeycomb Study
| Country | City | Gene | Status |
|---|---|---|---|
|
Australia |
South Brisbane,
Queensland |
GRIN1, GRIN2A, GRIN2B. GRIN2D |
Enrolling |
|
Canada |
Vancouver |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Canada |
Toronto, Ontario |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Germany |
Leipzig |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Germany |
München |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Italy |
Rome |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Italy |
Florence |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Netherlands |
Rotterdam |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Netherlands |
Utrecht |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Spain |
Madrid |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
Spain |
Barcelona |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
United Kingdom |
Glasgow |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
|
United Kingdom |
London |
GRIN1, GRIN2A, GRIN2B, GRIN2D |
Enrolling |
For the most complete information about this trial please see the trial’s page at Clinicaltrials.gov.
Who is eligible to participate?
- Age: ≥6 months to ≤12 years, with GRIN gene variants known to result in GoF of the NMDA receptor.
- Cohort 1 must have at least 1 observable motor seizure per week and ≥4 observable motor seizures (generalized or focal) during the prospective 4-week Observation Period and must have failed to obtain adequate seizure control with at least 2 antiseizure medications (ASMs) used at appropriate dose and duration.
- Cohort 2 must have significant behavioral and/or motor symptoms based on caregiver report with a CGI-S score ≥4.
- Participants cannot have had brain surgery, or be on other drugs that suppress the NMDA receptor such as memantine.
- Additional inclusion and exclusion criteria are included on the trial page at ClinicalTrials.gov.
- While clinical trials are an essential part of finding treatments and cures, CureGRIN advises families to consult with their neurologist and/or primary physician, and weigh potential risks and benefits before making a decision on what’s right for their child and family.
Contact information for Clinical sites
Australia
Queensland Children’s Hospital
South Brisbane, Queensland, Australia, 4101
Contact: Kate Riney kate.riney@health.qld.gov.au
Principal Investigator: Kate Riney
Canada
BC Children’s Hospital
Vancouver, Canada, BC V6H 3N1
Contact: Stephanie Kwok stephanie.kwok@cw.bc.ca
Principal Investigator: Mary Connolly
Canada
Hospital for Sick Children (Sick Kids)
Toronto, Ontario, Canada, M5G 1X8
Contact: Jashanpreet Sidhu jashanpreet.sidhu@sickkids.ca
Principal Investigator: Puneet Jain
Germany
Abteilung für Neuropädatrie, Klinik und Poliklinik für Kinder-und Jugendmedizin Universitätsklinikum Leipzig
Leipzig, Germany, 81377
Contact: Janina Gburek-Augustat, Dr. Med 0341/9726869 janina.gburek-augustat@medizin.uni-leipzig.de
Principal Investigator: Andreas Merkenschlager, Prof.Dr.Med 0341/9726869 Andreas.merkenschlager@medizin.uni-leipzig.de
Germany
KBO-Kinderzentrum München gemeinnützige GmbH
München, Germany, 81377
Contact: Marta Somorai, MD, PhD +49 89/3068-5800 marta.somorai@kbo.de
Sub-Investigator: Marta Somorai, MD, PhD
Principal Investigator: Volker Mall, MD, PhD
Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) – Ospedale Pediatrico Bambino Gesu
Roma, Lazio, Italy, 00165
Contact: Nicola Specchio, MD, PhD +39 066 859 2645 nicola.specchio@opbg.net
Contact: Sara Abbate, Pharmacist +39 066 859 4437 sara.abbate@opbg.net
Principal Investigator: Nicola Specchio, MD, PhD
Azienda Ospedaliero Universitaria Careggi (AOUC) Firenze – Azienda Ospedaliera Universitaria Meyer
Firenze, Toscana, Italy, 50139
Contact: Alessandra Boncristiano, MD +39 055 566 2573 alessandra.boncristiano@meyer.it
Contact: Renzo Guerrini, MD, PhD +39 055 566 2573 r.guerrini@meyer.it
Principal Investigator: Renzo Guerrini, MD, PhD
Netherlands
ERASMUS Medisch Centrum, Developmental & Genetic pediatrics
Rotterdam, Netherlands, 3015
Contact: Danielle Veenma, MD +31-6-50031296 grin.encore@erasmusmc.nl
Principal Investigator: Danielle Veenma, MD
UMC Utrecht – Wilhelmina Kinderziekenhuis, Polikliniek Kinderneurologie
Utrecht, Netherlands, 3508
Contact: Floor E Jansen, MD +31 0887554341 F.E.Jansen@umcutrecht.nl
Principal Investigator: Floor E Jansen, MD
Spain
Universitat de Barcelona – Hospital Sant Joan de Deu Barcelona (HSJDB)
Barcelona, Spain, 08950
Contact: Angeles Garcia Cazorla +34 93 253 21 00 angeles.garcia@sjd.es
Principal Investigator: Angeles Garcia Cazorla
Hospital Ruber Internacional
Madrid, Spain, 28034
Contact: Petra Gomez +34 91 387 52 50 ensayosepi@neurologiaclinica.es
Contact: Antonio Gil-Nagel, MD, PhD +34 91 387 52 50 gilnagel.ensayos@neurologiaclinica.es
Principal Investigator: Antonio Gil-Nagel, MD, PhD
UK
Royal Hospital for Children Glasgow
Glasgow, UK, G51 4TF
Contact: Helen Hart helen.hart@ggc.scot.nhs.uk
Contact: Anna Ryan anna.ryan@ggc.scot.nhs.uk
Principal Investigator: Sumeer Zuberi
UK
Great Ormond Street Hospital for Children NHS Foundation Trust
London, UK, WC1N3JH
Contact: Christopher Jackson Christopher.jackson@gosh.nhs.uk
Contact: Amy McTague
Cure GRI Disorders
You can help!
You can help us find a cure for GRI Disorders worldwide.
CureGRIN Foundation is a nonprofit, tax-exempt organization as defined in section 501(c)(3) of the Internal Revenue Code and, as such, contributions to CureGRIN are tax-deductible. Fund research. Save a life.
