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.

  • STATUS
    Recruiting
  • End date
    May 20, 2024
  • participants needed
    200
  • sponsor
    Noema Pharma AG
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Updated on 14 October 2022
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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.

Description

This study is designed to evaluate the efficacy and safety of basimglurant 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.

Details
Condition Trigeminal Neuralgia
Treatment Placebo, Basimglurant
Clinical Study IdentifierNCT05217628
SponsorNoema Pharma AG
Last Modified on14 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 (classical or idiopathic (with or without paroxysms)) trigeminal neuralgia as per the ICHD3 criteria confirmed by the study neurologist
Experience pain defined as at least three paroxysms per day, each rated at an intensity of 4 or more on a pain intensity numerical rating scale (PI-NRS) on at least four days per week. Pain should be present at least 2 months prior to study entry with or without continuous pain
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

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 (Diagnostic and Statistical Manual for
Mental Disorders, 5th edition) and/or substance abuse in the last six months [180
days], except for nicotine
Patient not willing to discontinue their current analgesics. Of note, gabapentin or
pregabalin will be discontinued during the first 2 weeks in Period 1 at the latest
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
Previous treatment with basimglurant
Treatment with antipsychotics within six months (180 days) prior to screening
Treatment of depressive symptoms with selective serotonin reuptake inhibitors is
permitted if started more than 6 weeks prior to screening. However, use of low dose
antipsychotics for reasons other than psychotic or bipolar disorders e.g., persistent
insomnia, is allowed
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.), or has a disease that
causes malabsorption
Body mass index > 33kg/m²
Patients with moderate or severe impaired hepatic function, i.e., Pugh-Child score B
or C
Patients with severe renal impairment, i.e., eGFR or creatinine clearance lower than
mL/min
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