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New drug aims to ease severe facial pain in trigeminal neuralgia

NCT ID NCT06571448

Symptom relief Sponsor: Shanghai SIMR Biotechnology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called SR750 in 138 people with trigeminal neuralgia, a condition that causes sudden, severe facial pain. Participants took either SR750 or a placebo for 6 weeks and recorded their daily pain levels. The goal was to see if SR750 reduces pain better than a placebo and is safe to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

138 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

trigeminal neuralgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trigeminal neuralgia

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.