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NCT05217628
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
Phase 2, PHASE3 trial testing Basimglurant in Trigeminal Neuralgia in 166 participants. Participants enrolled and being followed up; not accepting new ones.
2 February 2027
Quick facts
| Lead sponsor | Noema Pharma AG |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 166 |
| Start date | 11 January 2022 |
| Primary completion | 2 February 2027 |
| Estimated completion | 24 April 2027 |
| Sites | 34 locations across Denmark, Italy, United Kingdom, Germany, Poland, United States, Turkey (Türkiye), Spain |
Drugs / interventions tested
- Basimglurant — full drug profile →
- Placebo
Conditions studied
- Trigeminal Neuralgia — all drugs for Trigeminal Neuralgia →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05217628
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Trigeminal Neuralgia
Currently open trials in the same condition.
- NCT07252453 — Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia · NA · active not recruiting
- NCT06684275 — Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia · NA · recruiting
- NCT06620172 — CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia · NA · recruiting
- NCT06849219 — Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia · Phase 4 · active not recruiting
- NCT06216886 — OnabotulinumtoxinA for Trigeminal Neuralgia · Phase 4 · recruiting
Other Noema Pharma AG trials
Trials by the same sponsor.
- NCT06385795 — A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause · Phase 2 · completed
- NCT05583955 — A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) · Phase 2 · completed
- NCT05059327 — Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC · Phase 2 · completed
- NCT06019338 — A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05217628 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Noema Pharma AG
- Last refreshed: 23 January 2026
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