Trigeminal NeuralgiaPhase 2/3NCT05217628
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
A Phase 2/3 study testing Basimglurant in people with Trigeminal Neuralgia, run by Noema Pharma AG at 34 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Basimglurant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 11 Jan 2022to 24 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Body mass index > 39kg/m²
- Patients with moderate or severely impaired hepatic function, ie, Pugh-Child score C.
- Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30mL/min.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
United States8 sites
Beth Israel Deaconess Medical Center (Site #: 1004)
Boston, Massachusetts, 02215
University of Cincinnati (Site #: 1007)
Cincinnati, Ohio, 45219
Kaizen Brain Center (Site #: 1001)
La Jolla, California, 92037
Altea Research - Nevada - ClinEdge - PPDS (Site #1006)
Las Vegas, Nevada, 89102-1972
L & A Morales Healthcare INC (Site#: 1011)
Miami, Florida, 33142-3911
Columbia University - Irving Medical Center (Site #: 1008)
New York, New York, 10032
Vista Clinical Research,LLC (Site#: 1010)
Newnan, Georgia, 30265
University of South Florida (Site #: 1002)
Tampa, Florida, 33612
Turkey (Türkiye)8 sites
Afyon Kocatepe University Faculty of Medicine (Site #: 9005)
Afyonkarahisar, 03030
Uludag University Faculty of Medicine Hospital (Site #: 9001)
Bursa, 16059
Duzce University Health Application and Research Center (9008)
Düzce, Düzce, 81620
Istanbul University Istanbul Medical Faculty Hospital (Site #: 9003)
Istanbul, 34093
Bagcilar Medipol Mega University Hospital (Site #: 9002)
Istanbul, 34214
Kocaeli University Faculty of Medicine Hospital (Site #: 9004)
Kocaeli, 41001
Mersin University Faculty of Medicine Hospital (Site #: 9007)
Mersin, 33343
Selcuk University Medical Faculty (Site #: 9006)
Selçuklu, Konya, 42075
Italy5 sites
Azienda Ospedaliera Universitaria Careggi (Site #: 1806)
Florence, 50134
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta (Site #: 1804)
Milan, 20133
Università Campus Bio Medico Di Roma (Site #: 1805)
Rome, Lazio, 00128
IRCCS San Raffaele Pisana (Site #: 1801)
Rome, Lazio, 00163
La Sapienza-Università di Roma-Policlinico Umberto I (Site #: 1802)
Rome, Lazio, 00185
Poland5 sites
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Zespo (Site #: 2602)
Dąbrowa Górnicza, 41-300
Centrum Medyczne Linden (Site #: 2605)
Krakow, 30-721
FutureMeds - Lodzi - PPDS (Site #: 2606)
Lodz, 91-363
Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz (Site #: 2604)
Lublin, 20-090
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak (Site #: 2601)
Wroclaw, 52-210
Spain4 sites
Hospital Universitario Fundacion Jimenez Diaz (Site #: 1903)
Madrid, Madrid, 28040
Hospital Universitario La Paz - PPDS (Site #: 1907)
Madrid, Madrid, 28046
Hospital Universitario Virgen del Rocio - PPDS (Site #: 1904)
Seville, Sevilla, 41013
Hospital Clinico Universitario de Valencia (Site #: 1906)
Valencia, Valencia, 46010
United Kingdom2 sites
St. Thomas' Hospital (Site #: 2504)
London, London, SE1 7EH
St Pancras Clinical Research (Site #: 2503)
London, Middlesex, EC2Y 8EA
Denmark1 site
Danish Headache Center (Site #: 1201)
Glostrup Municipality, 2100
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Basimglurant, Placebo
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasimglurantDrug
Also called NOE-101
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.
PlaceboOther
Participant randomized to receive matching placebo once daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Change in pain as measured by the pain diary (TnED).
Measured: 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.
Measured: 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.
Measured: 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).
Impact on facial pain.
Measured: 12 weeks
Period 2: Frequency of attacks (paroxysms).
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 12 weeks
Period 2: Severity of attacks (paroxysms).
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 12 weeks
Period 2: Severity of continuous pain.
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 12 weeks
Period 2: Duration of continuous pain.
Impact on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 12 weeks
Period 2: Change in Patient Global Impression of Change (P-GIC).
Impact on facial pain.
Measured: 12 weeks
Period 2: Change in Medication Satisfaction Questionnaire (MSQ).
Impact on facial pain.
Measured: 12 weeks
Open Label Extension: Frequency of attacks (paroxysms).
Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 52 weeks
Open Label Extension: Severity of attacks (paroxysms).
Evaluate the continued efficacy of basimglurant on facial pain measured by patient rated scale via Penn-FPS-R
Measured: 52 weeks
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.
Evaluate the continued efficacy of basimglurant on facial pain.
Measured: 52 weeks
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.
Evaluate the continued efficacy of basimglurant on facial pain.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start11 Jan 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion24 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noema Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217628
- Sponsor's protocol ID
- NOE-TGN-201
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05217628
- Acronym / sponsor ID
- NOE-TGN-201
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Noema Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 24 Apr 2027 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Basimglurant/NOE-101 | Experimental | Drug: 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. |
| Arm B: Placebo | Placebo comparator | Other: Placebo- Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasimglurantAlso: NOE-101Period 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. | Drug | Arm A: Basimglurant/NOE-101 |
| PlaceboParticipant randomized to receive matching placebo once daily. | Other | Arm B: Placebo |
Primary outcome
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Time frame: 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.
Time frame: 12 weeks
To assess the maintenance of effect on pain.
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Time frame: 52 weeks
To evaluate the long-term safety of basimglurant daily dosing.
11 secondary outcomes
Period 2: Mean change in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale compared with Period 2 baseline (BL2).
Time frame: 12 weeks
Period 2: Frequency of attacks (paroxysms).
Time frame: 12 weeks
Period 2: Severity of attacks (paroxysms).
Time frame: 12 weeks
Period 2: Severity of continuous pain.
Time frame: 12 weeks
Period 2: Duration of continuous pain.
Time frame: 12 weeks
Period 2: Change in Patient Global Impression of Change (P-GIC).
Time frame: 12 weeks
Period 2: Change in Medication Satisfaction Questionnaire (MSQ).
Time frame: 12 weeks
Open Label Extension: Frequency of attacks (paroxysms).
Time frame: 52 weeks
Open Label Extension: Severity of attacks (paroxysms).
Time frame: 52 weeks
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.
Time frame: 52 weeks
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Basimglurant in people with Trigeminal Neuralgia, run by Noema Pharma AG at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Turkey (Türkiye), Italy, Poland, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events. (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.