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NCT05217628 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Trigeminal Neuralgia, sponsored by Noema Pharma.

Active
Registry status
Phase 2
Development phase
166
Enrollment target
20
Study locations

NCT05217628 is a Phase 2 study of Trigeminal Neuralgia that is active but no longer recruiting, run by Noema Pharma. The registered enrollment target is 166 participants, below the 5,751-participant average among 9 other Trigeminal Neuralgia trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05217628, a Phase 2 study of Trigeminal Neuralgia, is active but no longer recruiting, sponsored by Noema Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
166 participants
Enrollment target
20
Study locations

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

Trigeminal Neuralgia

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

6 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, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,751-participant average among 9 other Trigeminal Neuralgia trials with a reported enrollment target (97% lower). The listed sponsor is Noema Pharma, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05217628 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Lazio, Florida.

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.

What interventions are being tested in trial NCT05217628?

The interventions under investigation include: Placebo (OTHER), Basimglurant (DRUG).

Who is sponsoring clinical trial NCT05217628?

This trial is sponsored by Noema Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.