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NCT05217628

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

Active, enrolled Phase 2, PHASE3 Last updated 23 January 2026
What this trial tests

Phase 2, PHASE3 trial testing Basimglurant in Trigeminal Neuralgia in 166 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
11 January 2022
Primary endpoint
2 February 2027
24 April 2027

Quick facts

Lead sponsorNoema Pharma AG
PhasePhase 2, PHASE3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment166
Start date11 January 2022
Primary completion2 February 2027
Estimated completion24 April 2027
Sites34 locations across Denmark, Italy, United Kingdom, Germany, Poland, United States, Turkey (Türkiye), Spain

Drugs / interventions tested

Conditions studied

Sponsor

Noema Pharma AG — full company profile →

Who can join

Adults 18 to 75, any sex, with Trigeminal Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
    Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
  2. Potential novel therapeutic strategies for neuropathic pain.
    Du Z, Zhang J, Han X, Yu W, et al · · 2023 · cited 15× · PMID 37152429 · DOI 10.3389/fnmol.2023.1138798
  3. Pharmacology, Signaling and Therapeutic Potential of Metabotropic Glutamate Receptor 5 Negative Allosteric Modulators.
    Kos JA, Langiu M, Hellyer SD, Gregory KJ. · · 2024 · cited 3× · PMID 39698283 · DOI 10.1021/acsptsci.4c00213
  4. Abstracts from the 18 th European Headache Congress (EHC) : Rotterdam, The Netherlands. 4-7 December 2024.
    · 2025 · cited 1× · PMID 40545525 · DOI 10.1186/s10194-025-02062-8
  5. Qualitative validation of TnED©, an electronic instrument capturing pain dimensions in patients with trigeminal neuralgia.
    Tahiri AS, Dodhia SA, Chotaliya S, Ansari H, et al · · 2026 · PMID 42220290 · DOI 10.22514/jofph.2026.038

Verify or expand the search:

Other recruiting trials for Trigeminal Neuralgia

Currently open trials in the same condition.

Other Noema Pharma AG trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05217628.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing