BridgeMD
An international randomized clinical study, measuring safety and effectiveness of basimglurant for the treatment of pain in patients with Trigeminal Neuralgia
EU CTIS ID: 2024-514497-41-00
What this study is testing
Period 1: Run-in: To evaluate the safety, tolerability, and efficacy of basimglurant daily dosing 1.5 - 3.5 mg in pain associated with TN. Period 2: Double Blind: To assess the maintenance of effect on pain of doubleblind 12-week once daily dosing of basimglurant 1.5 – 3.5 mg compared with placebo in patients with TN. Open-Label Extension: To evaluate the long-term safety of basimglurant daily dosing 1.5-3.5 mg.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion Criteria (Summary): 1. Ability and willingness to provide written informed consent and to comply with the study procedures.
- 2. Fluency in the language of the investigator, study staff and the informed consent.
- 3. Age 18-75 years.
- 4. Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD3 criteria confirmed by the study neurologist.
- 5. 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.
- 6. 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).
You likely can't join if
- Exclusion Criteria (Summary): 1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
- 10. Any investigational drug within 90 days prior to initiation of study drug.
- Medical status: 11. 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.
- 12. 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.
- 13. Body mass index > 39 kg/m2.
- 14. Patients with severely impaired hepatic function, ie, Child-Pugh score C.
See the full eligibility criteria
- Inclusion Criteria (Summary): 1. Ability and willingness to provide written informed consent and to comply with the study procedures.
- 2. Fluency in the language of the investigator, study staff and the informed consent.
- 3. Age 18-75 years.
- 4. Diagnosis of primary trigeminal neuralgia (TN) as per the ICHD3 criteria confirmed by the study neurologist.
- 5. 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.
- 6. 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 (Summary): 1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted.
- 10. Any investigational drug within 90 days prior to initiation of study drug.
- Medical status: 11. 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.
- 12. 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.
- 13. Body mass index > 39 kg/m2.
- 14. Patients with severely impaired hepatic function, ie, Child-Pugh score C.
- 15. Patients with severe renal impairment, ie, eGFR or creatinine clearance lower than 30 mL/min.
- 2. Current or prior history of mania, or psychotic episodes.
- 3. History of DSM-5-defined substance dependence and/or substance abuse in the last six months [180 days], except for nicotine.
- 4. Patient not willing to discontinue their current TN analgesic medication.
- 5. Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week.
- 6. Known allergic reaction to the investigational drug or one of its components.
- 7. Patients with secondary TN as per the ICHD3 criteria.
- Medication history: 8. Previous treatment with basimglurant, except with the prior agreement of the medical monitor.
- 9. Treatment with antipsychotics within six months (180 days) of screening.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.