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Trigeminal NeuralgiaPhase 2NCT06571448

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

A Phase 2 study testing SR750 tablet in people with Trigeminal Neuralgia, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
SR750 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteChina
Study dates
16 Sep 2024to 24 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • China-Japan Friendship Hospital

    Beijing

Other trials in China

About this study

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

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.

Read the 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.

Being tested
SR750 tablet, Placebo
Keywords
Trigeminal Neuralgia, SR750
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR750 tabletDrug

    SR750 high dose BID orally for 6 weeks

  • SR750 tabletDrug

    SR750 low dose BID orally for 6 weeks

  • PlaceboDrug

    Placebo

Study groups in NCT06571448
Study groupRoleWhat they receive
SR750 high doseExperimentalNot described
Receives: Drug: SR750 tablet
SR750 low doseExperimentalNot described
Receives: Drug: SR750 tablet
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily Average Pain Score (DAPS)

    Change from baseline to week 6 in the weekly average of the daily average pain score (DAPS) of paroxysms using pain intensity numerical rating scale (PI-NRS).The PI-NRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

    Measured: up to week 6

Secondary outcomes (8)

  1. Proportion of responders

    Proportion of subjects who meets one of the following criteria,

    • Patient Global Impression of Change (PGIC) response of "Much Improved" or "Very Much Improved" at Week 6. Subjects will select a value to represent their overall status since the start of the study on a 7-point scale of PGIC on which 1 corresponds to "very much improved", 2 corresponds to "much improved", 3 corresponds to "slightly improved" 4 corresponds to "no change", 5 corresponds to "slightly worse", 6 corresponds to "much worse", and 7 corresponds to "very much worse".
    • A reduction of ≥2 points from baseline in mean pain score at Week 6
    • A reduction of ≥30% from baseline in mean pain score at Week 6
    • A reduction of ≥50% from baseline in mean pain score at Week 6
    • A reduction of ≥30% from baseline in mean number of paroxysms at Week 6
    • A reduction of ≥50% from baseline in mean number of paroxysms at Week 6
    • A reduction of ≥30% from baseline in mean worst pain score at Week 6

    Measured: up to week 6

  2. Mean pain score by week

    Change from baseline in weekly mean pain score. The daily pain score will be measured by PI-NRS described as above.

    Measured: up to week 6

  3. Mean worst pain score by week

    Change from baseline in mean worst pain score by week. The daily worst pain score will be measured by PI-NRS described as above.

    Measured: up to week 6

  4. Mean number of paroxysms by week

    Change from baseline in mean number of paroxysms by week

    Measured: up to week 6

  5. Mean continuous pain score by week

    Change from baseline in mean continuous pain score by week. The daily continuous pain score will be measured by PI-NRS described as above.

    Measured: up to week 6

  6. Proportion of subjects with continuous pain at week 6

    Change of proportion from baseline

    Measured: up to week 6

  7. Hospital Anxiety and Depression Scale (HADS)

    Change of HADS from baseline. The HADS is a self-administered questionnaire consisting of two subscales, one for anxiety (HADS-A Subscale) and the other for depression (HADS-D Subscale). Each subscale consists of 7 items, and subjects will rate each item as it applies to them 0 points = absence of anxiety or depression; 3 points = severe anxiety or depression. The HADS-A Subscale analyzes generalized anxiety states, including anxious feelings, restlessness, anxious thoughts, and panic attacks. The HADS-D Subscale focuses on states of loss of interest and reduced pleasure response (reduced enjoyment mood). Each subscale will receive a score from 0 to 21, with bigger number indicating more severe symptom.

    Measured: up to week 6

  8. Use of rescue medication

    Including the first time to use rescue medication, total amount and proportion

    Measured: up to week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start16 Sep 2024
  3. Primary completion26 Jan 2026
  4. Study completion24 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571448
Sponsor's protocol ID
SR750-202
Status last verified
Dec 2025
First submitted
22 Aug 2024
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SR750 tablet in people with Trigeminal Neuralgia, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Average Pain Score (DAPS) (time frame: up to week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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