Clinical trial NCT06571448: Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia
SR750
Lead sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 1:1:1 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.

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

Primary outcomes:
measure: Daily Average Pain Score (DAPS)
timeFrame: up to week 6
Secondary outcomes:
measure: Proportion of responders
timeFrame: up to week 6
measure: Mean pain score by week
timeFrame: up to week 6
measure: Mean worst pain score by week
timeFrame: up to week 6
measure: Mean number of paroxysms by week
timeFrame: up to week 6
measure: Mean continuous pain score by week
timeFrame: up to week 6
measure: Proportion of subjects with continuous pain at week 6
timeFrame: up to week 6
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to week 6
measure: Use of rescue medication
timeFrame: up to week 7
Other outcomes:
measure: Adverse events
timeFrame: up to week 7
measure: Plasma concentration of SR750 and its metabolite
timeFrame: up to day 43
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bifa Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: