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Evaluating Basimglurant for Trigeminal Neuralgia Pain Relief

A Phase II/III, Multicentre, 8-week run-in Phase Followed by a 12-week, Prospective, Parallel-group, Double-blind, Randomized Withdrawal, Placebo-controlled Study, With a 52 Week Open Label Extension, to Evaluate the Efficacy and Safety of Daily 1.5 to 3.5 mg Basimglurant in Patients With Pain Associated With Trigeminal Neuralgia With Suboptimal Response to Their Current Anti-pain Therapy.

PHASE2; PHASE3 · Noema Pharma AG · NCT05217628

This study is testing if a new medication called basimglurant can help adults with trigeminal neuralgia feel less facial pain.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNoema Pharma AG (industry)
Locations37 sites (La Jolla, California and 36 other locations)
Trial IDNCT05217628 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of basimglurant (NOE-101), a potent inhibitor of the metabotropic glutamate receptor 5 (mGluR5), in adults suffering from trigeminal neuralgia (TN). Participants will receive either the drug or a placebo, and their pain levels will be monitored using a patient pain diary and the Patient-reported Global Impression of Change (PGI-C). The goal is to determine if basimglurant can effectively reduce the duration and intensity of facial pain associated with TN compared to baseline measurements.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of primary trigeminal neuralgia experiencing significant daily pain.

Not a fit: Patients with major psychiatric diagnoses unrelated to trigeminal neuralgia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the debilitating pain experienced by patients with trigeminal neuralgia.

How similar studies have performed: While the approach of targeting mGluR5 for pain relief is promising, the specific efficacy of basimglurant in trigeminal neuralgia is still being evaluated and has not been widely tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria (Summary):

1. Ability and willingness to provide written informed consent and to comply with the study procedures.
2. Fluency in the language of the investigator, study staff and the informed consent.
3. Age 18-75 years.
4. Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD3 criteria confirmed by the study neurologist.
5. Experience pain due to TN and at baseline, experience at least 3 paroxysms per day of at least intensity of 4 or more on a pain intensity numerical rating scale (PI-NRS) during the last 7 days.
6. Female patients who are either sterile or menopausal. For female patients with childbearing potential, must be neither pregnant nor lactating (with appropriate contraceptive precautions and prior negative pregnancy tests).

Exclusion Criteria (Summary):

Patients who meet any of the following criteria will be excluded from participation in this study:

1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
2. Current or prior history of mania, or psychotic episodes.
3. History of DSM-5-defined substance dependence (Diagnostic and Statistical Manual for Mental Disorders, 5th edition) and/or substance abuse in the last six months \[180 days\], except for nicotine.
4. Patient not willing to discontinue their current TN analgesic medication.
5. Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
6. Known allergic reaction to the investigational drug or one of its components.
7. Patients with secondary TN as per the ICHD3 criteria.

   Medication history:
8. Previous treatment with basimglurant, except with the prior agreement of the medical monitor.
9. Treatment with antipsychotics within six months (180 days) of screening.
10. Any investigational drug within 90 days prior to initiation of study drug.

    Medical status:
11. Evidence of clinically significant, uncontrolled, unstable medical conditions or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
12. Subject has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.) that may, in the opinion of the investigator, may cause malabsorption, or has a disease of the GI tract that causes malabsorption.
13. Body mass index \> 39kg/m²
14. Patients with moderate or severely impaired hepatic function, ie, Pugh-Child score C.
15. Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30mL/min.

Where this trial is running

La Jolla, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Trigeminal Neuralgia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.