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 (including imaging either prior to study entry or during screening) of primary TN as per the ICHD3 criteria confirmed by the study neurologist or a healthcare professional with expertise in: • Classical TN, purely paroxysmal • Classical TN with concomitant continuous pain • Idiopathic TN, purely paroxysmal • Idiopathic TN with concomitant continuous pain 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 PI-NRS during the last 7 days. 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 (Section 8.2.5). Entry into Period 2 Only patients who meet the treatment response criteria below will be allowed to participate in Period 2: 1. For patients classified at study entry with paroxysms and concomitant continuous pain, at least 30% decrease in the total number or severity of paroxysms over the last 7 days of Period 1 as compared to the total number recorded in the last 7 days of screening (BL1) or at least 30% reduction in the mean severity of continuous pain experienced over the last 7 days of Period 1 compared to BL1 or at least 30% reduction in pain interference over the last 7 days of Period 1 compared to BL1. 2. For patients classified at study entry with paroxysms without concomitant continuous pain, at least 30% decrease in the total number or severity of paroxysms or pain interference over the last 7 days of Period 1 as compared to the total number recorded in the last 7 days of screening (BL1) 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 Patients who express suicidal ideation or have recent history of suicidal behavior and who, in the opinion of the investigator, are at risk of harming themselves. 2 Current or prior history of diagnosis of schizophrenia or chronic psychotic disorders. Patients with mood or anxiety disorders or TNrelated depressive symptoms are permitted. 3 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. 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 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: 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; Assess functional impairment Period 2: Double Blind: 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: 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 -Change in pain as measured by the pain diary (TnED). Incidence and severity of AEs. Laboratory, vital signs and cardiovascular safety will also be evaluated. - Changes in psychiatric status as measured by the BPRS. Treatment emergent suicidal ideation and behavior as measured by the S-STS. Period 2: Double Blind: -Time to Loss of Efficacy for each participant as determined by the Independent Adjudication Committee (IAC). Open-Label Extension (OLE): -Incidence and severity of adverse events. Laboratory, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Period 1: Run-In - Proportion of pain free days as measured by TnED. - Number and severity of attacks (paroxysms) as well as duration and severity of continuous pain compared with BL1, as measured by TnED. - Changes in pain interference with daily activities compared to BL1, as measured by TnED. - Mean change from BL1 to Week 8 in the total patient-rated PENN-FPS-R - PGI-C from BL1 to Week 8 - Patient reported rating of the MSQ. - Changes from BL1 to Week 8 in SDS. Period 2: Double Blind: - Proportion of pain free days as measured by TnED in the double-blind randomized withdrawal period until end of double-blind randomized treatment or start of pain rescue medication intake. - Number and severity of attacks (paroxysms) as well as duration and severity of continuous pain compared with BL1, as measured by TnED: • During the last 7 days until end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period. • During the last 7 days until end of double-blind randomized withdrawal period. - Changes in pain interference with daily activities compared to BL2, as measured by TnED: • During the last 7 days until end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period. • During the last 7 days until end of double-blind randomized withdrawal period. - Change at the end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period in the total patient-rated PENN-FPS-R compared with BL2 - PGI-C at the end of double-blind randomized treatment or start of rescue medication intake during the double-blind randomized withdrawal period - Patient reported rating of the MSQ - Incidence and severity of AEs. Laboratory and cardiovascular safety will also be evaluated. Changes in psychiatric status as measured by the BPRS. Treatment emergent suicidal ideation and | — |
Countries
Denmark, Germany, Italy, Poland, Spain, Türkiye, United Kingdom, United States
Contacts
Public ContactAdults Clinical Development
Noema Pharma
Outcome results
None listed