Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia

Launched by SHANGHAI SIMR BIOTECHNOLOGY CO., LTD. · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called SR750 to see how well it works, how safe it is, and how well patients tolerate it for treating trigeminal neuralgia, a condition that causes severe facial pain. Participants in the study will receive either SR750 or a placebo (a dummy pill with no active medication) for 6 weeks. They will keep a daily diary to track their pain levels. The entire study will last up to 11 weeks for each participant.

To be eligible for this trial, patients must have been diagnosed with trigeminal neuralgia for at least three months and have experienced significant pain. They should be willing to stop taking certain medications during the study. It's important to note that women who are pregnant or breastfeeding cannot participate. Certain other medical conditions or previous treatments may also exclude potential participants. The study is not yet recruiting, but it aims to help improve treatment options for those suffering from this painful condition.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria for at least 3 months prior to screening
• • Subjects must have completed at least 5 daily pain score and experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 on PI-NRS during the seven days of run-in period.
• • Willing and able to undergo washout of prohibited medication as per protocol requirements and refrain from use of the prohibited medication throughout the study period.
• • Female subjects must be non-pregnant and non-lactating.
• Key Exclusion Criteria:
• • Secondary trigeminal neuralgia
• • Painful trigeminal neuropathies
• • Other pains that cannot be clearly differentiated from the pain associated with TN or may interfere with the pain assessment
• • Subjects have previously undergone microvascular decompression (MVD), sensory rhizotomy of trigeminal nerve, radiofrequency ablation (RFA), percutaneous balloon compression (PBC), permanent lesion of trigeminal semilunar ganglion, botulinum toxin type A for the treatment of TN within 6 months prior to screening. Subjects with severe complication after therapeutic procedure would also be excluded.
• • Known history of human immunodeficiency virus (HIV) or active infection of hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum