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New pill could ease the 'Suicide Disease' for patients failed by current meds

NCT ID NCT05217628

Symptom relief Sponsor: Noema Pharma AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a daily drug called basimglurant for adults with trigeminal neuralgia, a condition causing severe facial pain often called the 'suicide disease.' The trial includes 166 people who still have pain despite current treatments. After an 8-week run-in on the drug, participants are randomly assigned to continue basimglurant or switch to placebo for 12 weeks to see if the drug maintains pain relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Basimglurant (also called NOE-101), a daily oral drug
What this could lead to
If it works, this could provide a new pain relief option for people with trigeminal neuralgia who don't get enough help from current treatments.
What could go wrong
This is an early-to-mid stage trial with only 166 people. The drug may not prove better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

166 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

trigeminal neuralgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trigeminal neuralgia

Contacts and locations

Locations

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

    Afyonkarahisar, 03030, Turkey (Türkiye)

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

    Las Vegas, Nevada, 89102-1972, United States

  • Azienda Ospedaliera Universitaria Careggi (Site #: 1806)

    Florence, 50134, Italy

  • Bagcilar Medipol Mega University Hospital (Site #: 9002)

    Istanbul, 34214, Turkey (Türkiye)

  • Beth Israel Deaconess Medical Center (Site #: 1004)

    Boston, Massachusetts, 02215, United States

  • Centrum Medyczne Linden (Site #: 2605)

    Krakow, 30-721, Poland

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

    New York, New York, 10032, United States

  • Danish Headache Center (Site #: 1201)

    Glostrup Municipality, 2100, Denmark

  • Duzce University Health Application and Research Center (9008)

    Düzce, Düzce, 81620, Turkey (Türkiye)

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

    Milan, 20133, Italy

  • FutureMeds - Lodzi - PPDS (Site #: 2606)

    Lodz, 91-363, Poland

  • Hospital Clinico Universitario de Valencia (Site #: 1906)

    Valencia, Valencia, 46010, Spain

  • Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903)

    Madrid, Madrid, 28040, Spain

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

    Madrid, Madrid, 28046, Spain

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

    Seville, Sevilla, 41013, Spain

  • IRCCS San Raffaele Pisana (Site #: 1801)

    Rome, Lazio, 00163, Italy

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

    Istanbul, 34093, Turkey (Türkiye)

  • Kaizen Brain Center (Site #: 1001)

    La Jolla, California, 92037, United States

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

    Kocaeli, 41001, Turkey (Türkiye)

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

    Miami, Florida, 33142-3911, United States

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

    Rome, Lazio, 00185, Italy

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

    Wroclaw, 52-210, Poland

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

    Mersin, 33343, Turkey (Türkiye)

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

    Dąbrowa Górnicza, 41-300, Poland

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

    Lublin, 20-090, Poland

  • Selcuk University Medical Faculty (Site #: 9006)

    Selçuklu, Konya, 42075, Turkey (Türkiye)

  • St Pancras Clinical Research (Site #: 2503)

    London, Middlesex, EC2Y 8EA, United Kingdom

  • St. Thomas' Hospital (Site #: 2504)

    London, London, SE1 7EH, United Kingdom

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

    Bursa, 16059, Turkey (Türkiye)

  • University of Cincinnati (Site #: 1007)

    Cincinnati, Ohio, 45219, United States

  • University of South Florida (Site #: 1002)

    Tampa, Florida, 33612, United States

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

    Rome, Lazio, 00128, Italy

  • Universitätsklinikum Bonn (Site #: 1707)

    Bonn, 53127, Germany

  • Vista Clinical Research,LLC (Site#: 1010)

    Newnan, Georgia, 30265, United States

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