What is the mechanism of action of this treatment?

Trigeminal Neuralgia (TN) is often treated with medications that stabilize nerve activity or reduce pain transmission. Common treatments include anticonvulsants like carbamazepine and oxcarbazepine, which inhibit sodium channels to reduce nerve excitability, and muscle relaxants like baclofen, which act on GABA receptors to decrease nerve signal transmission. Basimglurant, a negative allosteric modulator of mGluR5, works by inhibiting the metabotropic glutamate receptor 5, potentially reducing the excitatory neurotransmission involved in TN pain. Understanding these mechanisms is crucial for TN patients as it helps tailor treatments to effectively manage their severe pain by targeting specific pathways involved in nerve signal transmission.

What side effects are associated with this type of intervention?

Common treatments for Trigeminal Neuralgia include anticonvulsants like carbamazepine and oxcarbazepine, which can cause side effects such as dizziness, drowsiness, nausea, and ataxia. Lamotrigine, another anticonvulsant, may lead to severe cutaneous hypersensitivity and requires slow dose titration. Baclofen, a muscle relaxant, can cause sedation and muscle weakness. Gabapentin and pregabalin, used for neuropathic pain, may result in dizziness, somnolence, and peripheral edema. Basimglurant, being studied for TN, may have side effects similar to other mGluR5 modulators, potentially including dizziness, fatigue, and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for Trigeminal Neuralgia, primarily focusing on anticonvulsants such as carbamazepine and oxcarbazepine, which are considered first-line treatments. Other medications like gabapentin and pregabalin are also used, although they are not specifically approved for TN. There is limited information on FDA-approved treatments that are similar to Basimglurant, a negative allosteric modulator of mGluR5. Most current treatments do not target the same pathway as Basimglurant, which is being studied for its potential efficacy in TN.

What other types of research exist?

Promising novel alternatives to Basimglurant for Trigeminal Neuralgia patients include: 1) Sodium channel blockers like Carbamazepine and Oxcarbazepine, which are first-line treatments. 2) Gabapentinoids such as Gabapentin and Pregabalin, which are used for neuropathic pain. 3) Botulinum toxin type A injections, which have shown efficacy in reducing pain. 4) Non-pharmacological options like high-frequency spinal cord stimulation and microvascular decompression surgery, which are considered for refractory cases.

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Glutamate Receptor Antagonist

Basimglurant for Trigeminal Neuralgia

Phase 2 & 3

Recruiting

Research Sponsored by Noema Pharma AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability and willingness to provide written informed consent and to comply with the study procedures.

Diagnosis of primary (classical or idiopathic (with or without paroxysms)) trigeminal neuralgia as per the ICHD3 criteria confirmed by the study neurologist.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial is testing a medication called basimglurant to see if it can help reduce severe facial pain in adults with Trigeminal Neuralgia. The medication works by blocking a specific receptor in the nervous system to lower pain signals. Researchers will measure changes in pain using patient diaries and feedback.

Who is the study for?

Adults aged 18-75 with a confirmed diagnosis of primary trigeminal neuralgia, experiencing significant pain despite current treatments. Participants must be fluent in the study language and capable of giving informed consent. Women must be non-pregnant, non-lactating, and using contraception if of childbearing potential.

What is being tested?

The trial is testing the effectiveness and safety of basimglurant (1.5mg - 3.5mg) for adults with trigeminal neuralgia compared to a placebo. The goal is to see if this medication can reduce the intense facial pain associated with TN.

What are the potential side effects?

While specific side effects are not listed here, participants should watch for any unusual symptoms or changes in their health since basimglurant could potentially cause reactions similar to other medications used for neuropathic pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are able to give informed consent and comply with the study procedures.

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I have been diagnosed with trigeminal neuralgia by a neurologist.

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I am between 18 and 75 years old.

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My condition is diagnosed as trigeminal neuralgia by a neurologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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.

Secondary study objectives

Open Label Extension: Frequency of attacks (paroxysms).

Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.

Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.

+8 more

Other study objectives

Period 1: Duration of continuous pain compared with BL1.

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.

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

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: Basimglurant/NOE-101Experimental Treatment1 Intervention

* 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.

Group II: Arm B: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Basimglurant

2015

Completed Phase 1

~60

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Trigeminal Neuralgia (TN) is often treated with medications that stabilize nerve activity or reduce pain transmission. Common treatments include anticonvulsants like carbamazepine and oxcarbazepine, which inhibit sodium channels to reduce nerve excitability, and muscle relaxants like baclofen, which act on GABA receptors to decrease nerve signal transmission. Basimglurant, a negative allosteric modulator of mGluR5, works by inhibiting the metabotropic glutamate receptor 5, potentially reducing the excitatory neurotransmission involved in TN pain. Understanding these mechanisms is crucial for TN patients as it helps tailor treatments to effectively manage their severe pain by targeting specific pathways involved in nerve signal transmission.