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

NCT05217628 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: NOE-TGN-201
• Study Type: interventional
• Target: 166
• Locations: 8 countries
• Sites: 34

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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (3)

• Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.

  Change in pain as measured by the pain diary (TnED).

  8 weeks

• 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.

  To assess the maintenance of effect on pain.

  12 weeks

• Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.

  To evaluate the long-term safety of basimglurant daily dosing.

  52 weeks

Secondary Outcomes (11)

• 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

• Period 2: Frequency of attacks (paroxysms).

  12 weeks

• Period 2: Severity of attacks (paroxysms).

  12 weeks

• Period 2: Severity of continuous pain.

  12 weeks

• Period 2: Duration of continuous pain.

  12 weeks

Other Outcomes (8)

• Period 1: Mean change from Period 1 baseline (BL1) to Week 8 in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale.

  8 weeks

• Period 1: Measure Global Impression of change from Period 1 baseline (BL1) to Week 8.

  8 weeks

• Period 1: Number and severity of attacks (paroxysms).

  8 weeks

Study Arms (2)

Arm A: Basimglurant/NOE-101

EXPERIMENTAL

* 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.

Drug: Basimglurant

Arm B: Placebo

PLACEBO COMPARATOR

\- Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules.

Other: Placebo

Interventions

Basimglurant DRUG

Period 1: Basimglurant 1.5 to 3.5 mg QD titrated on individual tolerability. Period 2: Patients randomized to receive either double blind Basimglurant at the tolerated dose from Period 1 or Placebo. OLE: Open label Basimglurant at the dose tolerated from Period 2, patients previously assigned placebo in period to be titrated to the Period 1.

Also known as: NOE-101

Arm A: Basimglurant/NOE-101

Placebo OTHER

Participant randomized to receive matching placebo once daily.

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to provide written informed consent and to comply with the study procedures.
• Fluency in the language of the investigator, study staff and the informed consent.
• Age 18-75 years.
• Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD-3 criteria confirmed by the study neurologist.
• Experience pain due to TN and at baseline, experience at least 3 paroxysms per day of at least intensity of 4 or more on a pain intensity numerical rating scale (PI-NRS) during the last 7 days.
• Female patients who are either sterile or menopausal. For female patients with childbearing potential, must be neither pregnant nor lactating (with appropriate contraceptive precautions and prior negative pregnancy tests).

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in this study:
• Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
• Current or prior history of mania, or psychotic episodes.
• History of DSM-5-defined substance dependence and/or substance abuse in the last six months \[180 days\], except for nicotine.
• Patient not willing to discontinue their current TN analgesic medication.
• Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
• Known allergic reaction to the investigational drug or one of its components.
• Patients with secondary TN as per the ICHD-3 criteria.
• Medication history:
• Previous treatment with basimglurant, except with the prior agreement of the medical monitor.
• Treatment with antipsychotics within six months (180 days) of screening.
• Any investigational drug within 90 days prior to initiation of study drug.
• Medical status:
• Evidence of clinically significant, uncontrolled, unstable medical conditions or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
• Subject has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.) that may, in the opinion of the investigator, may cause malabsorption, or has a disease of the GI tract that causes malabsorption.

Sponsors & Collaborators

• Noema Pharma AG: lead

Study Sites (34)

Kaizen Brain Center (Site #: 1001)

La Jolla, California, 92037, United States

Location

L & A Morales Healthcare INC (Site#: 1011)

Miami, Florida, 33142-3911, United States

Location

University of South Florida (Site #: 1002)

Tampa, Florida, 33612, United States

Location

Vista Clinical Research,LLC (Site#: 1010)

Newnan, Georgia, 30265, United States

Location

Beth Israel Deaconess Medical Center (Site #: 1004)

Boston, Massachusetts, 02215, United States

Location

Altea Research - Nevada - ClinEdge - PPDS (Site #1006)

Las Vegas, Nevada, 89102-1972, United States

Location

Columbia University - Irving Medical Center (Site #: 1008)

New York, New York, 10032, United States

Location

University of Cincinnati (Site #: 1007)

Cincinnati, Ohio, 45219, United States

Location

Danish Headache Center (Site #: 1201)

Glostrup Municipality, 2100, Denmark

Location

Universitätsklinikum Bonn (Site #: 1707)

Bonn, 53127, Germany

Location

Università Campus Bio Medico Di Roma (Site #: 1805)

Rome, Lazio, 00128, Italy

Location

IRCCS San Raffaele Pisana (Site #: 1801)

Rome, Lazio, 00163, Italy

Location

La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802)

Rome, Lazio, 00185, Italy

Location

Azienda Ospedaliera Universitaria Careggi (Site #: 1806)

Florence, 50134, Italy

Location

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804)

Milan, 20133, Italy

Location

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602)

Dąbrowa Górnicza, 41-300, Poland

Location

Centrum Medyczne Linden (Site #: 2605)

Krakow, 30-721, Poland

Location

FutureMeds - Lodzi - PPDS (Site #: 2606)

Lodz, 91-363, Poland

Location

Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604)

Lublin, 20-090, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601)

Wroclaw, 52-210, Poland

Location

Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903)

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario La Paz - PPDS (Site #: 1907)

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904)

Seville, Sevilla, 41013, Spain

Location

Hospital Clinico Universitario de Valencia (Site #: 1906)

Valencia, Valencia, 46010, Spain

Location

Duzce University Health Application and Research Center (9008)

Düzce, Düzce, 81620, Turkey (Türkiye)

Location

Selcuk University Medical Faculty (Site #: 9006)

Selçuklu, Konya, 42075, Turkey (Türkiye)

Location

Afyon Kocatepe University Faculty of Medicine (Site #: 9005)

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

Uludag University Faculty of Medicine Hospital (Site #: 9001)

Bursa, 16059, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003)

Istanbul, 34093, Turkey (Türkiye)

Location

Bagcilar Medipol Mega University Hospital (Site #: 9002)

Istanbul, 34214, Turkey (Türkiye)

Location

Kocaeli University Faculty of Medicine Hospital (Site #: 9004)

Kocaeli, 41001, Turkey (Türkiye)

Location

Mersin University Faculty of Medicine Hospital (Site #: 9007)

Mersin, 33343, Turkey (Türkiye)

Location

St. Thomas' Hospital (Site #: 2504)

London, London, SE1 7EH, United Kingdom

Location

St Pancras Clinical Research (Site #: 2503)

London, Middlesex, EC2Y 8EA, United Kingdom

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 1, 2022
• Study Start: January 11, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): April 24, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

IT (5); DK (1); US (8); DE (1); GB (2); PL (5); TU (8); ES (4)