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ACTIVE NOT RECRUITING Phase 2

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

NCT05217628 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • OTHER Placebo
  • DRUG Basimglurant

Study Locations (20)

Other

  • Danish Headache Center (Site #: 1201) — Glostrup Municipality
  • Universitätsklinikum Bonn (Site #: 1707) — Bonn
  • Azienda Ospedaliera Universitaria Careggi (Site #: 1806) — Florence
  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804) — Milan
  • Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602) — Dąbrowa Górnicza
  • Centrum Medyczne Linden (Site #: 2605) — Krakow
  • FutureMeds - Lodzi - PPDS (Site #: 2606) — Lodz
  • Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604) — Lublin
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601) — Wroclaw

Lazio

  • Università Campus Bio Medico Di Roma (Site #: 1805) — Rome
  • IRCCS San Raffaele Pisana (Site #: 1801) — Rome
  • La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802) — Rome

Florida

  • L & A Morales Healthcare INC (Site#: 1011) — Miami
  • University of South Florida (Site #: 1002) — Tampa

California

  • Kaizen Brain Center (Site #: 1001) — La Jolla

Georgia

  • Vista Clinical Research,LLC (Site#: 1010) — Newnan

Massachusetts

  • Beth Israel Deaconess Medical Center (Site #: 1004) — Boston

Nevada

  • Altea Research - Nevada - ClinEdge - PPDS (Site #1006) — Las Vegas

New York

  • Columbia University - Irving Medical Center (Site #: 1008) — New York

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2022-01-11
Est. Completion 2027-04-24
Phase Phase 2

Sponsor

Noema Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05217628

The ClinicalTrials.gov registry entry for NCT05217628 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noema Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Trigeminal Neuralgia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05217628 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Lazio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05217628 about?

NCT05217628 is a clinical study titled "An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.". 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...

What is the current status of trial NCT05217628?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2022-01-11. Estimated completion is 2027-04-24.

What conditions does trial NCT05217628 study?

This clinical trial studies the following conditions: Trigeminal Neuralgia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05217628?

The interventions under investigation include: Placebo (OTHER), Basimglurant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05217628?

This trial is sponsored by Noema Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05217628 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial