Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392009
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
Astroscape A Study of Radiprodil on Safety Tolerability Pharmacokinetics and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
Sponsor:
GRIN Therapeutics Inc
Organization:
GRIN Therapeutics Inc
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
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-201 is a phase 1B2A 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 Blong-term treatment period The treatment period in Part B may be extended based on a favorable benefitrisk profile
Detailed Description:
Approximately 20 participants with TSC and 10 participants with FCD type II will be enrolled
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
ScreeningObservation Period up to six6 weeks Investigators assess eligibility followed by an Observation Period at least four4 weeks to evaluate seizure frequency
Titration Period approx four4 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 twelve12 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 doesnt 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 one1 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 hisher last dose of radiprodil The participant will have one 1 last visit at the end of the safety Follow-up Period
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
ScreeningObservation Period up to six6 weeks Investigators assess eligibility followed by an Observation Period at least four4 weeks to evaluate seizure frequency
Titration Period approx four4 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 twelve12 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 doesnt 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 one1 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 hisher last dose of radiprodil The participant will have one 1 last visit at the end of the safety Follow-up Period
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 |
|---|---|---|---|
| 2023-506301-20-00 | OTHER | CTIS | None |