Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05818943
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-02-22
Brief Title:
Honeycomb Evaluation of Radiprodil in Children with GRIN-related Disorder
Sponsor:
GRIN Therapeutics Inc
Organization:
GRIN Therapeutics Inc
Study Overview
Official Title:
A Multicenter Study to Assess the Safety Tolerability Pharmacokinetics and Effect on Seizures and Behavioral Symptoms of Multiple Individually Titrated Doses of Radiprodil in Children with GRIN-related Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study RAD-GRIN-101 is a phase 1B trial to assess safety tolerability PK and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function GoF genetic variant 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
After the end of part A all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period Part B
Subjects participation in the study is expected to last up to six months in Part A
After the end of part A all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period Part B
Detailed Description:
The effect of radiprodil is assessed in two 2 cohorts of pediatric participants one 1 cohort of participants with treatment-resistant seizures with or without behavioral symptoms Cohort 1 and one 1 cohort of participants with behavioral symptoms but no qualifying seizures Cohort 2 caused by Gain-of-Function GoF variants in the GRIN gene As the daily doses of radiprodil will be individually titrated for every participant and all the participants will receive the study drug this is in effect a single group study
This study is divided into the following periods
PART A
ScreeningObservation Period 35 days Investigators assess eligibility followed by a four4- week Observation Period to evaluate seizure frequency andor behavioral symptoms
Titration Period approx 51 days Overnight stay to administer radiprodil twice daily to assigned dose level assessing plasma concentrations safety and tolerability during the titration period Once a safe and potentially effective dose has been established the participant will immediately enter the Maintenance Period
Maintenance Period up to 53 days During the Maintenance Period the participant will continue to take the highest safe and potentially effective dose as identified during the Titration Period At the end of the Maintenance Period there will be an additional overnight stay when the participant will either be invited to take part in Part B or enter the Tapering and Safety Follow-up Period
Tapering 15 days and Safety Follow-up Period 14 days the participant who doesnt take part in the long-term treatment period Part B will need to taper off ie gradually decrease the study medicine for 15 days and enter a safety Follow-up Period 14 days In this case the participant will make one 1 last visit to the study site 14 days after hisher last dose of radiprodil
PART B
Long-Term Treatment Period not specified Participation in Part B of the study at the dose established during part A will be continued until such time as either the participant withdrawsis withdrawn from the study or sponsor terminates the study During this period there will be four 4 visits per year two2 of which will require overnight stays At the end of the Long-Term Treatment Period the participant will enter the Tapering and Safety Follow-up Period
Tapering 15 days and Safety Follow-up Period 14 days the participant will need to taper off the study medicine for 15 days and enter a safety Follow-up Period of 14 days In this case the participant will make one 1 last visit to the study site 14 days after hisher last dose of radiprodil
This study is divided into the following periods
PART A
ScreeningObservation Period 35 days Investigators assess eligibility followed by a four4- week Observation Period to evaluate seizure frequency andor behavioral symptoms
Titration Period approx 51 days Overnight stay to administer radiprodil twice daily to assigned dose level assessing plasma concentrations safety and tolerability during the titration period Once a safe and potentially effective dose has been established the participant will immediately enter the Maintenance Period
Maintenance Period up to 53 days During the Maintenance Period the participant will continue to take the highest safe and potentially effective dose as identified during the Titration Period At the end of the Maintenance Period there will be an additional overnight stay when the participant will either be invited to take part in Part B or enter the Tapering and Safety Follow-up Period
Tapering 15 days and Safety Follow-up Period 14 days the participant who doesnt take part in the long-term treatment period Part B will need to taper off ie gradually decrease the study medicine for 15 days and enter a safety Follow-up Period 14 days In this case the participant will make one 1 last visit to the study site 14 days after hisher last dose of radiprodil
PART B
Long-Term Treatment Period not specified Participation in Part B of the study at the dose established during part A will be continued until such time as either the participant withdrawsis withdrawn from the study or sponsor terminates the study During this period there will be four 4 visits per year two2 of which will require overnight stays At the end of the Long-Term Treatment Period the participant will enter the Tapering and Safety Follow-up Period
Tapering 15 days and Safety Follow-up Period 14 days the participant will need to taper off the study medicine for 15 days and enter a safety Follow-up Period of 14 days In this case the participant will make one 1 last visit to the study site 14 days after hisher last dose of radiprodil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000317-14 | EUDRACT_NUMBER | None | None |