Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571448
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Efficacy Safety and Tolerability of SR750 in Patients With Trigeminal Neuralgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-blind and Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of SR750 in Patients With Trigeminal Neuralgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacysafety and tolerability of SR750 in patients with trigeminal neuralgia TN Patients will receive SR750 study drug or placebo for 6 weeks and keep a diary of daily pain The study duration for each patient is up to 11 weeks
Detailed Description:
This is a phase 2 randomized double-blind study comparing SR750 with placebo in patients with trigeminal neuralgia It consists of a screening period a double-blind treatment period and a post-treatment safety follow-up period Baseline pain intensity and number of paroxysms will be taken in the run-in period of screening period and will be checked for eligibility Around 162 eligible subjects will be recruited and randomized into three arms at 111 ratio to receive SR750 high dose twice a day BID SR750 low dose BID or placebo BID for 6 weeks Subjects investigators all clinical study site staffs and the Sponsor will remain blinded to treatment assignment during the study Subjects will be asked to record the number of paroxysms of pain severity of daily average pain of paroxysms and severity of daily worst pain in e-diary over the last 24 hours every night before going to bed After completion of double-blind period subjects will continue to complete the safety follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None