Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia (NCT06571448) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
China138 participantsStarted 2024-09-16
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy,safety 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Key Inclusion Criteria:
* Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria
* Subjects must have experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 and ≤8 on PI-NRS during the five days prior to randomization.
* 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