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

Phase 2

Recruiting

• Conditions: Trigeminal Neuralgia
• Interventions: Other: Placebo; Drug: Basimglurant

• Registration Number: NCT05217628
• Lead Sponsor: Noema Pharma AG

Brief 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.

Detailed Description

This study is designed to evaluate the efficacy and safety of basimglurant (NOE-101) in patients with TN. Basimglurant is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in both central and peripheral nervous system. Inhibition of the mGluR5 receptor has shown therapeutic potential for pain associated with conditions such as TN. The drug has been shown to have a favorable safety profile in adults, children and adolescents. The aim of the study is to determine whether Basimglurant decreases both duration and intensity of facial pain associated with TN by use of a patient pain diary and the Patient-reported Global Impression of Change (PGI-C) compared to baseline.

Study Timeline

• Study First Submitted: 2021-12-15
• Study Start: 2022-01-11
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-10-31
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Placebo	Placebo	- Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules.
Arm A: Basimglurant/NOE-101	Basimglurant	* Period 1 (Run-in: Baseline1 to Week 8): Basimglurant once daily dosing starting dose 1.5mg * Period 2 (Double blind: Weeks 9 to 20): Participants will receive double-blind treatment with Basimglurant once daily. * Open-label Extension (OLE): On completion of Period 2, participants will be offered open label treatment with Basimglurant in an open label extension for up to 52 weeks.

Primary Outcome Measures

Name	Time	Method
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.	52 weeks	To evaluate the long-term safety of basimglurant daily dosing.
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.	8 weeks	Change in pain as measured by the pain diary (TnED).
Period 2: Time to Loss of Efficacy or pain recurrence defined as the confirmed increase in the number of weekly paroxysms or re-emergence of continuous pain and/or the need for rescue medication.	12 weeks	To assess the maintenance of effect on pain.

Secondary Outcome Measures

Name	Time	Method
Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2).	12 weeks	Impact on facial pain.
Open Label Extension: Severity of attacks (paroxysms).	52 weeks	Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Severity of continuous pain.	12 weeks	Impact on facial pain measured by patient rated scale via Penn-FPS-R
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.	52 weeks	Evaluate the continued efficacy of basimglurant on facial pain.
Period 2: Frequency of attacks (paroxysms).	12 weeks	Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Change in Medication Satisfaction Questionnaire (MSQ).	12 weeks	Impact on facial pain.
Open Label Extension: Frequency of attacks (paroxysms).	52 weeks	Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.	52 weeks	Evaluate the continued efficacy of basimglurant on facial pain.
Period 2: Severity of attacks (paroxysms).	12 weeks	Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Duration of continuous pain.	12 weeks	Impact on facial pain measured by patient rated scale via Penn-FPS-R
Period 2: Change in Patient Global Impression of Change (P-GIC).	12 weeks	Impact on facial pain.

Trial Locations

Locations (37)

Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903); 🇪🇸 Madrid, Spain

Hospital Universitario La Paz - PPDS (Site #: 1907); 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904); 🇪🇸 Sevilla, Spain

Hospital Clinico Universitario de Valencia (Site #: 1906); 🇪🇸 Valencia, Spain

Selcuk University Medical Faculty (Site #: 9006); 🇹🇷 Selçuklu, Konya, Turkey

Centrum Medyczne Linden (Site #: 2605); 🇵🇱 Kraków, Poland

Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604); 🇵🇱 Lublin, Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601); 🇵🇱 Wrocław, Poland

FutureMeds - Lodzi - PPDS (Site #: 2606); 🇵🇱 Łódź, Poland

Kaizen Brain Center (Site #: 1001); 🇺🇸 La Jolla, California, United States

L & A Morales Healthcare INC (Site#: 1011); 🇺🇸 Miami, Florida, United States

University of South Florida (Site #: 1002); 🇺🇸 Tampa, Florida, United States

Vista Clinical Research,LLC (Site#: 1010); 🇺🇸 Newnan, Georgia, United States

Beth Israel Deaconess Medical Center (Site #: 1004); 🇺🇸 Boston, Massachusetts, United States

Altea Research - Nevada - ClinEdge - PPDS (Site #1006); 🇺🇸 Las Vegas, Nevada, United States

Columbia University - Irving Medical Center (Site #: 1008); 🇺🇸 New York, New York, United States

University of Cincinnati (Site #: 1007); 🇺🇸 Cincinnati, Ohio, United States

Danish Headache Center (Site #: 1201); 🇩🇰 Glostrup, Denmark

Kopfschmerzzentrum Frankfurt (Site #: 1706); 🇩🇪 Frankfurt am Main, Hessen, Germany

Universitätsklinikum Essen (Site #: 1702); 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Universitätsklinikum Bonn (Site #: 1707); 🇩🇪 Bonn, Germany

St. Ansgar Krankenhaus Höxter -Klinikum Weser Egge (Site #: 1701); 🇩🇪 Höxter, Germany

Università Campus Bio Medico Di Roma (Site #: 1805); 🇮🇹 Roma, Lazio, Italy

IRCCS San Raffaele Pisana (Site #: 1801); 🇮🇹 Roma, Lazio, Italy

La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802); 🇮🇹 Roma, Lazio, Italy

Azienda Ospedaliera Universitaria Careggi (Site #: 1806); 🇮🇹 Florence, Italy

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804); 🇮🇹 Milano, Italy

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602); 🇵🇱 Dąbrowa Górnicza, Poland

Afyon Kocatepe University Faculty of Medicine (Site #: 9005); 🇹🇷 Afyonkarahisar, Turkey

Uludag University Faculty of Medicine Hospital (Site #: 9001); 🇹🇷 Bursa, Turkey

Duzce University Health Application and Research Center (9008); 🇹🇷 Düzce, Turkey

Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003); 🇹🇷 Istanbul, Turkey

Bagcilar Medipol Mega University Hospital (Site #: 9002); 🇹🇷 Istanbul, Turkey

Kocaeli University Faculty of Medicine Hospital (Site #: 9004); 🇹🇷 Kocaeli, Turkey

Mersin University Faculty of Medicine Hospital (Site #: 9007); 🇹🇷 Mersin, Turkey

St Pancras Clinical Research (Site #: 2503); 🇬🇧 London, Middlesex, United Kingdom

St. Thomas' Hospital (Site #: 2504); 🇬🇧 London, United Kingdom