Evaluating Basimglurant for Trigeminal Neuralgia Pain Relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kaizen Brain Center (Site #: 1001)
  La Jolla, California, United States Recruiting
• L & A Morales Healthcare INC (Site#: 1011)
  Miami, Florida, United States Recruiting
• University of South Florida (Site #: 1002)
  Tampa, Florida, United States Recruiting
• Vista Clinical Research,LLC (Site#: 1010)
  Newnan, Georgia, United States Recruiting
• Columbia University - Irving Medical Center (Site #: 1008)
  New York, New York, United States Recruiting
• University of Cincinnati (Site #: 1007)
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Noema Pharma
• Email: clinicaltrials@noemapharma.com
• Phone: Please contact via email:

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring the link between emotion, memory, and chronic facial pain

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.