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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: Active Phase 2 study of Trigeminal Neuralgia, sponsored by Noema Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in pain as measured by the pain diary (TnED).
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
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2022-01-11 |
| Est. Completion | 2027-04-24 |
| Phase | Phase 2 |
What the registry record for NCT05217628 still lists
NCT05217628 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 5,751-participant average among 9 other Trigeminal Neuralgia trials with a reported enrollment target (97% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT05217628's enrollment target sits among peer trials
166 3rd of 9 higher than 7 of 9 other Trigeminal Neuralgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Trigeminal Neuralgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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