An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia. (NCT05217628)
A Phase II/III, Multicentre, 8-week run-in Phase Followed by a 12-week, Prospective, Parallel-group, Double-blind, Randomized Withdrawal, Placebo-controlled Study, With a 52 Week Open Label Extension, to Evaluate the Efficacy and Safety of Daily 1.5 to 3.5 mg Basimglurant in Patients With Pain Associated With Trigeminal Neuralgia With Suboptimal Response to Their Current Anti-pain Therapy.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Kaizen Brain Center (Site #: 1001) — La Jolla, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (34 Sites)
Showing the first 25 of 34 sites.
- Kaizen Brain Center (Site #: 1001) — La Jolla, California
- L & A Morales Healthcare INC (Site#: 1011) — Miami, Florida
- University of South Florida (Site #: 1002) — Tampa, Florida
- Vista Clinical Research,LLC (Site#: 1010) — Newnan, Georgia
- Beth Israel Deaconess Medical Center (Site #: 1004) — Boston, Massachusetts
- Altea Research - Nevada - ClinEdge - PPDS (Site #1006) — Las Vegas, Nevada
- Columbia University - Irving Medical Center (Site #: 1008) — New York, New York
- University of Cincinnati (Site #: 1007) — Cincinnati, Ohio
- Danish Headache Center (Site #: 1201) — Glostrup Municipality,
- Universitätsklinikum Bonn (Site #: 1707) — Bonn,
- Università Campus Bio Medico Di Roma (Site #: 1805) — Rome, Lazio
- IRCCS San Raffaele Pisana (Site #: 1801) — Rome, Lazio
- La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802) — Rome, Lazio
- 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,
- Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903) — Madrid, Madrid
- Hospital Universitario La Paz - PPDS (Site #: 1907) — Madrid, Madrid
- Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904) — Seville, Sevilla
- Hospital Clinico Universitario de Valencia (Site #: 1906) — Valencia, Valencia
- Duzce University Health Application and Research Center (9008) — Düzce, Düzce
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Trigeminal Neuralgia
- MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia — Baltimore, Maryland
- RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery — Birmingham, Alabama
- Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia — Newark, New Jersey
- Trigeminal Evoked Responses to Improve Rhizotomy — Minneapolis, Minnesota
- RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia — Sherbrooke,
Explore by condition: All Trigeminal Neuralgia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.