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

Description

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 practice. This study is designed to evaluate the efficacy and safety of 1.5mg - 3.5mg basimglurant in adults with TN.

Conditions

Trigeminal Neuralgia

Study Overview

Study Details

Study overview

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 practice. This study is designed to evaluate the efficacy and safety of 1.5mg - 3.5mg basimglurant in adults with TN.

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.

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

Condition
Trigeminal Neuralgia
Intervention / Treatment

-

Contacts and Locations

La Jolla

Kaizen Brain Center (Site #: 1001), La Jolla, California, United States, 92037

Tampa

University of South Florida (Site #: 1002), Tampa, Florida, United States, 33612

Boston

Beth Israel Deaconess Medical Center (Site #: 1004), Boston, Massachusetts, United States, 02215

Las Vegas

Altea Research - Nevada - ClinEdge - PPDS (Site #1006), Las Vegas, Nevada, United States, 89102-1972

New York

Columbia University - Irving Medical Center (Site #: 1008), New York, New York, United States, 10032

Cincinnati

University of Cincinnati (Site #: 1007), Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 75 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Noema Pharma AG,

    Study Record Dates

    2026-01-31