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

NCT05217628 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2026-01-23

No results posted yet for this study

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 practice.

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

Conditions

  • Trigeminal Neuralgia

Interventions

DRUG

Basimglurant

Period 1: Basimglurant 1.5 to 3.5 mg QD titrated on individual tolerability. Period 2: Patients randomized to receive either double blind Basimglurant at the tolerated dose from Period 1 or Placebo. OLE: Open label Basimglurant at the dose tolerated from Period 2, patients previously assigned placebo in period to be titrated to the Period 1.

OTHER

Placebo

Participant randomized to receive matching placebo once daily.

Sponsors & Collaborators

  • Noema Pharma AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2027-02-02
Completion
2027-04-24
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217628 on ClinicalTrials.gov