Trigeminal neuralgia MedDRA version: 20.0 Level: PT Classification code 10044652 Term: Trigeminal neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Noema Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all entry criteria will be eligible to participate in the study: At study entry (Period 1), patients must meet all the following criteria: 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 (classical or idiopathic (with or without paroxysms)) trigeminal neuralgia as per the ICHD3 criteria confirmed by the study neurologist: • Classical TN, purely paroxysmal • Classical TN with concomitant continuous pain • Idiopathic TN, purely paroxysmal • Idiopathic TN with concomitant continuous pain 5. 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. This pain should be present during at least 2 months prior to study entry and may be associated with or without continuous pain. 6. Female patients who are either sterile or menopausal. For female patients with childbearing potential: A female patient is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • For women of child bearing potential (WOCBP), female patients should be using an acceptable contraceptive method during the study intervention period (at a minimum until 28 days after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. • WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 28 days before the first dose of study intervention. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in this study: 1. Current or prior history of any major psychiatric diagnoses unrelated to TN. Patients with TN-related depressive symptoms are permitted. 2. History of Diagnostic and Statistical Manual for Mental Disorders, 5th edition defined substance dependence and/or substance abuse in the last six months [180 days], except for nicotine. 3. 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. 4. Use of opioids, except for pain control on a prn basis as long as it does not exceed 2 days per week. 5. Known allergic reaction to the investigational drug or one of its components. Medication history: 6. Previous treatment with basimglurant. 7. 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. 8. Any investigational drug within 90 days prior to initiation of study drug. Medical status: 9. 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. 10. 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. 11. Body mass index > 33kg/m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Period 1: Run-in: To evaluate the safety of basimglurant daily dosing 1.5-3.5 mg Period 2: Double Blind: To assess the maintenance of effect on pain of double-blind 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.;Secondary Objective: Period 1: Run-in: To evaluate the efficacy of 8-week once daily treatment with basimglurant on pain associated with trigeminal neuralgia on the following disease aspects: -Impact on Facial Pain -Patient perceived change of the pain -Quantitative and qualitative pain assessments -Pain freedom -Patient medication satisfaction Period 2: Double Blind: To evaluate the effect of double-blind treatment of once daily dose of basimglurant versus placebo on the following disease aspects: • Impact on facial pain • Pain frequency and severity • Patient perceived perception of change in pain • Patient medication satisfaction • Safety of basimglurant once daily dosing 1.5-3.5 mg compared with placebo • The impact of pain on general activities of daily living Open-Label Extension: To evaluate the continued efficacy of basimglurant with once daily dosing 1.5-3.5 mg on the following disease aspects: • Impact on facial pain • Pain frequency and severity • Patient perceived severity of pain;Primary end point(s): Period 1: Run-In - Incidence and severity of adverse events. Laboratory, vital signs and cardiovascular safety will also be evaluated. Period 2: Double Blind: -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. Open-Label Extension (OLE): -Incidence and severity of adverse events. Laboratory, vital signs and cardiovascular safety will also be evaluated.;Timepoint(s) of evaluation of this end point: PERIOD 1 Week 1, Day 8 Week 2, Day 15 Week 3, Day 22 Wee | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Period 1: Run-In Mean change from Period 1 baseline (BL1) to Week 8 in the total patient-rated Brief Pain Inventory-Facial (BPI-F) scale. - Measure Global Impression of change from Period 1 baseline (BL1) to Week 8. - Number and severity of attacks (paroxysms) as well as duration and severity of continuous pain compared with BL1. - Number of pain free days. - Patient reported rating of the Medication Satisfaction Questionnaire (MSQ). Period 2: Double Blind: -Mean change in the total patient-rated Brief Pain Inventory-Facial (BPI-F) scale compared with Period 2 baseline (BL2) -Frequency and severity of attacks (paroxysms) as well as severity and duration of continuous pain captured in patient diary cards. -Measure Global Impression of change as compared with Period 2 baseline (BL2) -Patient reported rating of the Medication Satisfaction Questionnaire (MSQ) -Incidence and severity of adverse events. Laboratory and cardiovascular safety will also be evaluated. -Recorded ratings of interference of pain with patient’s activities captured in patient diary cards. Open-Label Extension (OLE): -Mean scores in the total patient-rated Brief Pain Inventory-Facial (BPI-F) scale. -Frequency and severity of attacks (paroxysms) as well as severity and duration of continuous pain captured in patient diary cards. -Measure Global Impression of severity as captured by PGI-S.;Timepoint(s) of evaluation of this end point: PERIOD 1 Week 1, Day 8 Week 2, Day 15 Week 3, Day 22 Week 4, Day 29 Week 5, Day 36 Week 6, Day 43 Week 7, Day 50 Week 8, Day 57 PERIOD 2 Week 10, Day 71 Week 12, Day 85 Week 14, Day 99 Week 16, Day 113 Week 18, Day 127 Week 20, Day 141 / EoT Period 2 Open Label Extension: Month 3, 6, 9, 12 | — |
Countries
Denmark, Germany, Italy, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactAdults Clinical Development
Noema Pharma
Outcome results
None listed