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 States166 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 range18 Years – 75 Years
SexALL
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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
✕. 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.
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.