Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.

Lead Sponsor:

Noema Pharma AG

Conditions:

Trigeminal Neuralgia

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

Brief Summary

Trigeminal neuralgia (TN), also called "tic douloureux", is the most common form of craniofacial neuropathic pain and is considered the cause of one of the most painful afflictions known in medical pr...

Detailed Description

This study is designed to evaluate the efficacy and safety of basimglurant (NOE-101) in patients with TN. Basimglurant is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which control...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Summary):
  • Ability and willingness to provide written informed consent and to comply with the study procedures.
  • Fluency in the language of the investigator, study staff and the informed consent.
  • Age 18-75 years.
  • Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD3 criteria confirmed by the study neurologist.
  • 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.
  • 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:
  • Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
  • Current or prior history of mania, or psychotic episodes.
  • 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.
  • Patient not willing to discontinue their current TN analgesic medication.
  • Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
  • Known allergic reaction to the investigational drug or one of its components.
  • Patients with secondary TN as per the ICHD3 criteria.
  • Medication history:
  • Previous treatment with basimglurant, except with the prior agreement of the medical monitor.
  • Treatment with antipsychotics within six months (180 days) of screening.
  • Any investigational drug within 90 days prior to initiation of study drug.
  • Medical status:
  • 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.
  • 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.
  • Body mass index \> 39kg/m²
  • Patients with moderate or severely impaired hepatic function, ie, Pugh-Child score C.
  • Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30mL/min.

Exclusion

    Key Trial Info

    Start Date :

    January 11 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2027

    Estimated Enrollment :

    166 Patients enrolled

    Trial Details

    Trial ID

    NCT05217628

    Start Date

    January 11 2022

    End Date

    February 1 2027

    Last Update

    July 11 2025

    Active Locations (34)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (34 locations)

    1

    Kaizen Brain Center (Site #: 1001)

    La Jolla, California, United States, 92037

    2

    L & A Morales Healthcare INC (Site#: 1011)

    Miami, Florida, United States, 33142-3911

    3

    University of South Florida (Site #: 1002)

    Tampa, Florida, United States, 33612

    4

    Vista Clinical Research,LLC (Site#: 1010)

    Newnan, Georgia, United States, 30265