An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia. (NCT05217628) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.
United States, Denmark, Germany166 participantsStarted 2022-01-11
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Timeframe: 8 weeks
2
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.
Timeframe: 12 weeks
3
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.