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Clinical Trials in the USA / NCT05217628
Active, not recruiting Phase 2/3

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

NCT05217628 · tracked via the Priya Life Science USA tracker
Sponsor
Noema Pharma AG
Phase
Phase 2/3
Started
2022-01-11
Last updated
2026-01-23

Condition(s) studied

Trigeminal Neuralgia

Investigational drug(s) / intervention(s)

BasimglurantPlacebo

Basimglurant: 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.

Placebo: Participant randomized to receive matching placebo once daily.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria (Summary): 1. Ability and willingness to provide written informed consent and to comply with the study procedures. 2. Fluency in the language of the investigator, study staff and the informed consent. 3. Age 18-75 years. 4. Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD-3 criteria confirmed by the study neurologist. 5. 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. 6. 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). Exclusion Criteria (Summary): Patients who meet any of the following criteria will be excluded from participation in this study: 1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted. 2. Current or prior history of mania, or psychotic episodes. 3. History of DSM-5-defined substance dependence and/or substance abuse in the last six months \[180 days\], except for nicotine. 4. Patient not willing to discontinue their current TN analgesic medication. 5. Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week. 6. Known allergic reaction to the investigational drug or one of its components. 7. Patients with secondary TN as per the ICHD-3 criteria. Medication history: 8. Previous treatment with basimglurant, except with the prior agreement of the medical monitor. 9. Treatment with antipsychotics within six months (180 days) of screening. 10. Any investigational drug within 90 days prior to initiation of study drug. Medical status: 11. 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. 12. 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. 13. Body mass index \> 39kg/m² 14. Patients with moderate or severely impaired hepatic function, ie, Pugh-Child score C. 15. Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30mL/min.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
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 Denmark
Universitätsklinikum Bonn (Site #: 1707) Bonn Germany
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 Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804) Milan Italy
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602) Dąbrowa Górnicza Poland
Centrum Medyczne Linden (Site #: 2605) Krakow Poland
FutureMeds - Lodzi - PPDS (Site #: 2606) Lodz Poland
Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604) Lublin Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601) Wroclaw Poland
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
Selcuk University Medical Faculty (Site #: 9006) Selçuklu Konya
Afyon Kocatepe University Faculty of Medicine (Site #: 9005) Afyonkarahisar Turkey (Türkiye)
Uludag University Faculty of Medicine Hospital (Site #: 9001) Bursa Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003) Istanbul Turkey (Türkiye)
Bagcilar Medipol Mega University Hospital (Site #: 9002) Istanbul Turkey (Türkiye)
Kocaeli University Faculty of Medicine Hospital (Site #: 9004) Kocaeli Turkey (Türkiye)
Mersin University Faculty of Medicine Hospital (Site #: 9007) Mersin Turkey (Türkiye)
St. Thomas' Hospital (Site #: 2504) London London
St Pancras Clinical Research (Site #: 2503) London Middlesex

More Noema Pharma AG trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05217628 on ClinicalTrials.gov ↗ ← All trials in the USA